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RecruitingNCT05476627Updated Aug 16, 2022

Risk Factors and Multiomics Study of Chronic Kidney Disease Caused by Metabolic Diseases

An observational study in Chronic Kidney Diseases, Hypertension and Diabetes Mellitus, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-16.

Sponsored by Peking Union Medical College Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 80 Years
Sex
All
01

Study summary

With the development of China's economy, people's living standard have improved, and the dietary structure have changed. Metabolic diseases, such as hypertension, diabetes, hyperuricemia and obesity have gradually become an important health burden in China. The pathophysiological mechanism of renal injury caused by metabolic diseases has always been a hotspot of research. Currently, it is believed that various mechanisms including the activation of Renin-Angiotensin-Aldosterone System, vascular endothelial dysfunction, oxidative stress and inflammatory process may be involved. Although there are differences in renal pathological manifestations caused by different metabolic diseases, the kidney will eventually present ischemic changes and fibrosis with the progression of the disease. So there must be some common pathogenesis. This study is designed to build a disease cohort of patients with chronic kidney disease caused by metabolic diseases, to identify risk factors leading to disease progression and to explore biomarkers for early diagnosis and treatment of kidney damage.

02

Conditions studied

  • Chronic Kidney Diseases
  • Hypertension
  • Diabetes Mellitus
  • Hyperuricemia
  • Obesity

Keywords

  • chronic kidney disease
  • metabolic diseases
  • biomarker
  • functional imaging techniques
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's planned enrollment of 200 is close to the median of 213 across 834 observational studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population is consecutively enrolled from outpatient and inpatient department of our hospital.

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

  • The diagnosis of metabolic diseases were confirmed;
  • Be able to understand the process of the research;
  • Volunteer for participation and be able to sign the .

Exclusion criteria

Exclusion Criteria:

  • Age \<18 yrs or >80yrs;
  • Patients with primary and secondary glomerular diseases
  • Patients with other comorbidities that could affect the volume or the components of the kidney, such as renal cysts, polycystic kidney disease, medullary sponge kidney, hydronephrosis, renal artery stenosis, renal vein thrombosis and/or renal tumors;
  • for MRI examination;
  • Pregnant or lactation patients;
  • Patients with unstable vital signs, failure of other organs or dysphoria.
Terms in these criteria, in plain language(2)

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hypertension Group

    Diagnostic Test: Biomarkers

  • Diabetes Group

    Diagnostic Test: Biomarkers

  • Hyperuricemia

    Diagnostic Test: Biomarkers

  • Obesity

    Diagnostic Test: Biomarkers

Interventions

  • Diagnostic testBiomarkers

    Blood,urine and imaging biomarkers for early diagnosis and prediction of prognosis.

06

What researchers measure

Primary outcomes

  1. Number of Participants with End Stage Renal Disease

    End Stage Renal Disease

    Time frame: 3 years

  2. Number of Participants with Adverse cardiovascular events

    Adverse cardiovascular events

    Time frame: 3 years

  3. Number of Participants with all cause death

    All cause death

    Time frame: 3 years

Secondary outcomes

  1. Number of Participants with eGFR decline

    the decline of eGFR during follow-up

    Time frame: 3 years

  2. Number of Participants with Complications of CKD

    The complications of CKD

    Time frame: 3 years

  3. Life quality assessment with short form-36 (SF-36)

    The SF-36 is a patient-reported instrument designed to assess overall health status; it is usually utilized to measure patients' quality of life and used primarily in research. Increasing SF-36 scores are indicative of improving health status.

    Time frame: 3 years

  4. Advanced Intelligence Assessment with Mini-Mental State Examination (MMSE)

    The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point) . While different cutoff points have been used across studies, scores ≤23 are most commonly regarded as abnormal and indicative of cognitive impairment.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — De-privatized data are to be shared with other researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05476627
Responsible party
Limeng Chen (director of the department of nephrology, Peking Union Medical College Hospital) — Principal investigator
First posted
Jul 27, 2022
Start date
Jul 1, 2022
Primary completion
Jul 1, 2025 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Aug 16, 2022

Study contacts

Yan Liu
Contact
liuyanpumch@163.com
+86-15811568692
Limeng Chen
principal investigator · Peking Union Medical College Hospital

Oversight

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

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