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RecruitingNCT05057403UKIDSUpdated Dec 5, 2025

UK Imaging Diabetes Study Seeing Diabetes Clearly

An observational study in Type2 Diabetes, sponsored by Perspectum. Recruiting at 12 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Perspectum · Observational

From the registry’s dates

  • Started May 2022; still recruiting 4 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

Prospective, observational cohort study to cross-sectionally assess the health of multiple organs, using multiparametric abdominal magnetic resonance imaging (MRI) scan, and understand if resulting MRI metrics can predict future clinical events over a period of 5 years, in adult patients with type 2 diabetes lacking history of cardiovascular disease.

Read the detailed description

This will be a multi-site study adopting a prospective, observational cohort study design. There will be no intervention to the standard of care. Study participants will be enrolled in this study for a total of 5 years, with only 1 month of active participation. Participants will be required to attend a screening visit and 2 study visits. The screening visit will involve a medical review and receiving informed consent based on the participant information leaflet already communicated to the patient, pre-screening. The first study visit- baseline (visit 1) - will involve anthropometric measurements and taking a blood and urine sample in order to perform standard of care measurements for type 2 diabetes at baseline and relevant circulating biomarkers. The second study visit will involve having a multi-organ, multiparametric MRI scan. Both visits will be within 28 days of the screening visit and carried out at local study sites.

MRI metrics of organ health, clinical outcome measurements, blood samples and urine samples will be collected to assess the natural history of diabetes disease progression. Participants will be asked to give consent for access to their medical records held at NHS England and, if available, at their local GP surgery or hospital. Medical records access will include Hospital admissions (Hospital Episode Statistics), and mortality data collected by the Office for National Statistics and provided by NHS England to meet the primary objective. This data will be collected at 1, 3 and 5 years after baseline assessment.

02

Conditions studied

  • Type2 Diabetes
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Perspectum is the lead sponsor of 27 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult participants, aged 18 years of age and over with type 2 diabetes lacking history of cardiovascular disease. Recruitment will be carried out from patients identified following diabetes or diabetic retinopathy diagnoses or via self-referral.

  1. Diabetes referral appointments
  2. Diabetic retinopathy referral appointments
  3. Primary care and diabetes clinics - including GP practices
  4. Participant Identification Centres
  5. Diabetes Eye Screening Programmes (DESP)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female at least 18 years of age and diagnosed with type 2 diabetes, with or without diabetic retinopathy.
  • Participant willing and able to give for participation in the study.

Exclusion criteria

Exclusion Criteria:

In 12 months prior to consent, evidence of existing cardiovascular event defined as at least one of:

  • myocardial infarction
  • ischaemic stroke
  • hospital admission/discharge for unstable angina
  • heart surgery
  • unstable angina
  • The participant may not enter the study if they have any to magnetic resonance imaging (standard MR exclusion criteria including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
  • Patients with known hepatitis, viral hepatitis, Wilson's disease or known significant structural renal tract abnormality.
  • Patients with known alcohol dependency.
  • Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Type 2 diabetes

    Patients with type 2 diabetes, especially individuals who have been diagnosed in the last three years

    Other: MRI

Interventions

  • OtherMRI

    MRI is not part of Pathway for patient with type two diabetes.

06

What researchers measure

Primary outcomes

  1. Baseline liver MR metrics on incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes) in people with type 2 diabetes, without history of CV.

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on cardiovascular clinical outcomes in a patient population with type 2 diabetes without history of cardiovascular disease.

    Time frame: 3 year from baseline

Secondary outcomes

  1. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death).

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 1 year from baseline

  2. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death).

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 3 years from baseline

  3. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death).

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 5 years from baseline

  4. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 1 year from baseline

  5. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 3 years from baseline

  6. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 5 years from baseline

  7. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 1 year from baseline

  8. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 3 years from baseline

  9. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 5 years from baseline

  10. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 1 year from baseline

  11. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 3 years from baseline

  12. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 5 years from baseline

  13. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 1 year from baseline

  14. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 3 years from baseline

  15. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 5 years from baseline

  16. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 1 year from baseline

  17. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 3 years from baseline

  18. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 5 years from baseline

  19. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 1 year from baseline

  20. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 3 years from baseline

  21. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 5 years from baseline

  22. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 1 year from baseline

  23. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 3 years from baseline

  24. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

    Time frame: 5 years from baseline

  25. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 1 year from baseline

  26. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase with incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 3 years from baseline

  27. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase with incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 5 years from baseline

  28. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death)

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 1 year from baseline

  29. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death)

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 3 years from baseline

  30. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death)

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 5 years from baseline

  31. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD)

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 1 year from baseline

  32. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD)

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 3 years from baseline

  33. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD)

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 5 years from baseline

  34. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 1 year from baseline

  35. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 3 years from baseline

  36. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 5 years from baseline

  37. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 1 year from baseline

  38. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 3 years from baseline

  39. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 5 years from baseline

  40. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 1 year from baseline

  41. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 3 years from baseline

  42. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 5 years from baseline

  43. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of CV death, liver death, renal death, cancer death, other death

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 1 year from baseline

  44. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of CV death, liver death, renal death, cancer death, other death

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 3 years from baseline

  45. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of CV death, liver death, renal death, cancer death, other death

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 5 years from baseline

  46. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 1 year from baseline

  47. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 3 years from baseline

  48. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 5 years from baseline

  49. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 1 year from baseline

  50. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 3 years from baseline

  51. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

    Time frame: 5 years from baseline

  52. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  53. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  54. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  55. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite severe renal disease events (renal replacement therapy, renal death)

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  56. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite severe renal disease events (renal replacement therapy, renal death)

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  57. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite severe renal disease events (renal replacement therapy, renal death)

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  58. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite mild renal disease events (incident CKD, change in stage of CKD)

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  59. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite mild renal disease events (incident CKD, change in stage of CKD)

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  60. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite mild renal disease events (incident CKD, change in stage of CKD)

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  61. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  62. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  63. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  64. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  65. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  66. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  67. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  68. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  69. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  70. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of CV death, liver death, renal death, cancer death, other death

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  71. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of CV death, liver death, renal death, cancer death, other death

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  72. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of CV death, liver death, renal death, cancer death, other death

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  73. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  74. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  75. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  76. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  77. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  78. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  79. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  80. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  81. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  82. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death)

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  83. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death)

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  84. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death)

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  85. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  86. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  87. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  88. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  89. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  90. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  91. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of lower limb amputations

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  92. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of lower limb amputations

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  93. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of lower limb amputations

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  94. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of all-cause mortality

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  95. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of all-cause mortality

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  96. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of all-cause mortality

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  97. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of CV death, liver death, renal death, cancer death, other death

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  98. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of CV death, liver death, renal death, cancer death, other death

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  99. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of CV death, liver death, renal death, cancer death, other death

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  100. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  101. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  102. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  103. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of non-hepatic cancer

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 1 year from baseline

  104. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of non-hepatic cancer

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 3 years from baseline

  105. The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of non-hepatic cancer

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

    Time frame: 5 years from baseline

  106. Prevalence of patients with evidence of metabolic dysfunction-associated steatotic liver disease in patients with diabetic retinopathy of different severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR)

    The co-prevalence of diabetic retinopathy (DR) and metabolic dysfunction-associated steatotic liver disease (MASLD), using multi-parametric abdominal MRI

    Time frame: 1 year from baseline

  107. Correlations between liver MRI metrics (organ volume, fat infiltration and fibroinflammation) and eye metrics (retinal layer thickness by OCT, discrete retinopathy scores)

    The correlation between severity of eye disease and MRI-derived metrics of liver disease using multiparametric MRI

    Time frame: 1 year from baseline

07

Study locations

11 of 12 sites recruiting
  • Woodlands Medical Centre
    Didcot, Oxfordshire OX11 0BB, United Kingdom
    Recruiting
  • Eynsham Medical Centre
    Eynsham, Oxfordshire OX29 4QB, United Kingdom
    Recruiting
  • White Horse Medical Practice
    Farringdon, Oxfordshire SN7 7YU, United Kingdom
    Recruiting
  • Windrush Medical Practice
    Witney, Oxfordshire OX26 6JS, United Kingdom
    Recruiting
  • The House Partnership
    Redhill, Surrey RH1 1EB, United Kingdom
    Recruiting
  • Swansea Bay University Health Board
    Baglan, Swansea SA12 7BR, United Kingdom
    Not yet recruiting
  • University Hospitals of Liverpool Group
    Liverpool, L9 7AL, United Kingdom
    Recruiting
  • Moorfields Eye Hospital NHS Foundation Trust
    London, United Kingdom
    Enrolling by invitation
  • The Manor Group
    Oxford, OX3 9BP, United Kingdom
    Recruiting
  • Hedena Health
    Oxford, OX3 9JA, United Kingdom
    Recruiting
  • St Bartholomew and Hollow Way Medical Practice
    Oxford, OX4 1XB, United Kingdom
    Recruiting
  • Oxford Community Diagnostic centre
    Oxford, OX42LL, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2022 (actual). Primary completion is estimated for Jun 2034, 145 months after the start.

Of 170 industry-sponsored observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 44. This study's planned 145 months is above that.

Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2021
First posted
Sep 27, 2021
StartActual
May 30, 2022
Primary completionEst.
Jun 2034
CompletionEst.
Jun 2034
Last update
Dec 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05057403
Lead sponsor
Perspectum
Collaborators
Moorfields Eye Hospital NHS Foundation Trust
Responsible party
Sponsor
First posted
Sep 27, 2021
Start date
May 30, 2022
Primary completion
Jun 2034 (estimated)
Completion
Jun 2034 (estimated)
Last update
Dec 5, 2025

Study contacts

Soubera Rymall, MSc
Contact
soubera.rymell@perspectum.com
00447919272482
Ravi Pattanshetty
principal investigator · Perspectum

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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