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Status unknownNCT04805853Updated Mar 18, 2021

Myocardial Pathological Changes in Patients of Type 2 Diabetes With or Without PCOS Using Cardiac Magnetic Resonance

An observational study in Type2 Diabetes and Polycystic Ovary Syndrome, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to female participants aged 30 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-18.

Sponsored by RenJi Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
561
Ages
30 Years to 40 Years
Sex
Female
01

Study summary

The study is prepared to use CMR technology for early screening of myocardial lesions in 561 age-matched women with type 2 diabetes without PCOS, with PCOS without type 2 diabetes and with type 2 diabetes combined with PCOS, compare the differences between the two groups of cardiomyocyte injury changes, and treat and follow-up with type 2 diabetes and PCOS in accordance with the current standard treatment guidelines for type 2 diabetes and PCOS, after 3 years of follow-up we will analyse the changes in cardiomyopathy, cardiac serological indicators, and heart function indicators,which can provide theoretical basis for early clinical intervention in the future.

Read the detailed description

So far, due to the lack of more sensitive noninvasive detection methods and indicators that suggest early cardiomyopathy, it is not clear whether type 2 diabetes combined with PCOS will lead to earlier and more progressive changes in cardiomyopathy, and whether there is a difference with type 2 diabetes alone and early cardiomyopathy in patients with simple PCOS.Compared with women with type 2 diabetes who did not combine polycystic Ovary Syndrome(PCOS) or PCOS did not combine with type 2 diabetes, patients with type 2 diabetes who combined PCOS had the characteristics of lower age of onset, longer exposure to high risk factors of CVD, and higher risk of cardiovascular disease on the basis of the dual pathophysiology of insulin resistance and hyperandrogenism.The purpose of this study is to find early cardiovascular disease of women with type 2 diabetes and PCOS and conduct early clinical intervention.

02

Conditions studied

  • Type2 Diabetes
  • Polycystic Ovary Syndrome
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's planned enrollment of 561 is above the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

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

04

Who can participate

Ages eligible
30 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Overweight/obese women with type 2 diabetes without PCOS, PCOS without type 2 diabetes, and type 2 diabetes with PCOS were expected enrolled in our study.

Inclusion criteria

  1. Age 30-40 years old;
  2. Overweight and obese women with/without type 2 diabetes without PCOS, PCOS without type 2 diabetes, and type 2 diabetes with PCOS;
  3. HbA1C 7-9% of patients with type 2 diabetes;
  4. Increased risk of cardiovascular disease (with any one of the following risk factors: hypertension, dyslipidemia, hyperuricemia, obesity, smoking);
  5. The diagnosis of PCOS is based on the 2003 Rotterdam criteria, the diagnosis of overweight/obesity is based on the WHO-WPR criteria, and the diagnosis criteria of type 2 diabetes is based on the 1998 WHO diagnosis criteria;
  6. Willing to participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Severe liver and kidney dysfunction (ALT is greater than 2.5 times the upper limit of normal, or Cr>132umol/l, or eGFR \<60 mL/min/1.73m2), psychosis, accompanied by severe infection, severe anemia, neutropenia disease;
  2. Congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, atrial fibrillation, viral myocarditis, infectious myocarditis, hyperthyroid heart disease, cardiac amyloidosis and other myocardial damage diseases, NYHA heart function classification ≥ Grade III, or the subject has had a clinical cardiovascular event in the past 3 months;
  3. Symptomatic heart failure in the past 6 months, or left ventricular ejection fraction \<35%;
  4. Self-reported or medical records are type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury, or other secondary diabetes (such as diabetes caused by Cushing syndrome, abnormal thyroid function, or acromegaly) ；
  5. Pregnancy;
  6. Participated in clinical trials of other drugs within 3 months;
  7. In the past 5 years, there have been treated or untreated organ system tumors (except local skin basal cell carcinoma), regardless of whether there is evidence of local recurrence or metastasis;
  8. A history of psychoactive substance abuse, including alcohol and a history of alcohol-related illnesses in the past 2 years;
  9. The subject is allergic to the contrast agent (gadopentetate meglumine injection);
  10. The subject has claustrophobia;
  11. The subject contains metal implants that are not suitable for cardiac magnetic resonance examination;
  12. Any conditions judged by the investigator that affect enrollment.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
561 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • type 2 diabetes without polycystic ovary syndrome

    The treatment of type 2 diabetes is based on the Chinese Medical Association Diabetes Branch '2017 China Type 2 Diabetes Prevention Guidelines' for lifestyle adjustment and diabetes drug treatment.The research physician decides the diabetes treatment measures of the research object; the blood sugar control goal is that glycosylated hemoglobin is less than 7%.

  • polycystic ovary syndrome without type 2 diabetes

    The treatment of polycystic ovary syndrome is based on the '2018 Polycystic Ovary Syndrome Chinese Diagnosis and Treatment Guidelines' by the Endocrinology Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association and the Guide Expert Group '2018 Polycystic Ovary Syndrome Expert consensus on diagnosis and treatment of endocrinology' for lifestyle and drug treatment.

  • polycystic ovary syndrome with type 2 diabetes

    Treatment is as above.

06

What researchers measure

Primary outcomes

  1. the change level of cardiac extracellular volume (ECV)

    Compared with baseline, the change level of cardiac extracellular volume (ECV) in patients with type 2 diabetes without PCOS, PCOS without type 2 diabetes, and type 2 diabetes with PCOS

    Time frame: 3 years

Secondary outcomes

  1. change in the level of troponin I (TNI)

    Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the serum index related to myocardial injury such as change of TNI in ng/ml.

    Time frame: 3 years

  2. change in the level of creatine kinase isoenzymes (CK-MB)

    Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the serum index related to myocardial injury such as change of CK-MB in IU/L.

    Time frame: 3 years

  3. change in the level of Brain Natriuretic Peptide (BNP)

    Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the serum index related to myocardial injury such as change of BNP in pg/ml.

    Time frame: 3 years

  4. change in the level of atrialnatriureticpeptide (ANP)

    Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the serum index related to myocardial injury such as change of ANP in pg/ml.

    Time frame: 3 years

  5. change in the level of left ventricular ejection fraction (LVEF)

    Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the cardiac functions change such as: left ventricular ejection fraction (LVEF) in %.

    Time frame: 3 years

  6. change in the level of left ventricular end diastolic pressure (LVEDP)

    Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the cardiac functions change such as: left ventricular end diastolic pressure (LVEDP) in kPa/mmHg.

    Time frame: 3 years

  7. change in the level of output per minute (CO) in L/min

    Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the cardiac functions change such as: output per minute (CO) in L/min.

    Time frame: 3 years

  8. change in the level of left ventricular diameter reduction rate (FS)

    Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the cardiac functions change such as: left ventricular diameter reduction rate (FS) in %.

    Time frame: 3 years

  9. Changes in score of Minnesota heart failure quality of life scale(LiHFe)

    Compared with the baseline in three groups, the changes of Minnesota heart failure quality of life scale(LiHFe) in score, higher scores mean a worse outcome. (Scores ranging from 0 to 105)

    Time frame: 3 years

  10. Changes in score of short form 12 questionnaire(SF-12)

    Compared with the baseline in three groups, the changes of SF-12 in score, higher scores mean a better outcome. (Scores ranging from 0 to 65)

    Time frame: 3 years

  11. Changes in score of Generalized Anxiety Disorder-7(GAD-7)

    Compared with the baseline in three groups, the changes of GAD-7 in score, higher scores mean a worse outcome. (Scores ranging from 0 to 21)

    Time frame: 3 years

  12. Changes in score of Patient Health Questionnaire-9(PHQ-9)

    Compared with the baseline in three groups, the changes of PHQ-9 in score, higher scores mean a worse outcome. (Scores ranging from 0 to 27)

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Renji Hospital Department of Endocrinology and Metabolism
    Shanghai, Shanghai 200127, China
    Recruiting
08

References and documents

Publications

  • Goodarzi MO, Dumesic DA, Chazenbalk G, Azziz R. Polycystic ovary syndrome: etiology, pathogenesis and diagnosis. Nat Rev Endocrinol. 2011 Apr;7(4):219-31. doi: 10.1038/nrendo.2010.217. Epub 2011 Jan 25. PubMed 21263450 ↗
  • Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004. PubMed 14711538 ↗
  • Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5. PubMed 19805654 ↗
  • Mahalingaiah S, Diamanti-Kandarakis E. Targets to treat metabolic syndrome in polycystic ovary syndrome. Expert Opin Ther Targets. 2015;19(11):1561-74. doi: 10.1517/14728222.2015.1101067. Epub 2015 Oct 21. PubMed 26488852 ↗
  • Lim SS, Davies MJ, Norman RJ, Moran LJ. Overweight, obesity and central obesity in women with polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod Update. 2012 Nov-Dec;18(6):618-37. doi: 10.1093/humupd/dms030. Epub 2012 Jul 4. PubMed 22767467 ↗
  • Baldani DP, Skrgatic L, Goldstajn MS, Vrcic H, Canic T, Strelec M. Clinical, hormonal and metabolic characteristics of polycystic ovary syndrome among obese and nonobese women in the Croatian population. Coll Antropol. 2013 Jun;37(2):465-70. PubMed 23940991 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04805853
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Mar 18, 2021
Start date
Feb 20, 2020
Primary completion
Feb 2022 (estimated)
Completion
Feb 2022 (estimated)
Last update
Mar 18, 2021

Study contacts

Tao Tao, Dr.
Contact
taotaosh76@163.com
86-021-68383073
Tao Tao, Dr.
principal investigator · RenJi Hospital

Oversight

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

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