Last updated: March 16, 2021
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Polycystic Ovarian Syndrome
Diabetes Prevention
Diabetes Mellitus, Type 2
Treatment
N/AClinical Study ID
NCT04805853
KY2020-198
Ages 30-40 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 30-40 years old;
- Overweight and obese women with/without type 2 diabetes without PCOS, PCOS withouttype 2 diabetes, and type 2 diabetes with PCOS;
- HbA1C 7-9% of patients with type 2 diabetes;
- Increased risk of cardiovascular disease (with any one of the following risk factors:hypertension, dyslipidemia, hyperuricemia, obesity, smoking);
- The diagnosis of PCOS is based on the 2003 Rotterdam criteria, the diagnosis ofoverweight/obesity is based on the WHO-WPR criteria, and the diagnosis criteria oftype 2 diabetes is based on the 1998 WHO diagnosis criteria;
- Willing to participate in this study and sign an informed consent form.
Exclusion
Exclusion Criteria:
- Severe liver and kidney dysfunction (ALT is greater than 2.5 times the upper limit ofnormal, or Cr>132umol/l, or eGFR <60 mL/min/1.73m2), psychosis, accompanied by severeinfection, severe anemia, neutropenia disease;
- Congenital heart disease, rheumatic heart disease, hypertrophic or dilatedcardiomyopathy, 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 clinicalcardiovascular event in the past 3 months;
- Symptomatic heart failure in the past 6 months, or left ventricular ejection fraction <35%;
- Self-reported or medical records are type 1 diabetes, single-gene mutation diabetes,diabetes caused by pancreatic injury, or other secondary diabetes (such as diabetescaused by Cushing syndrome, abnormal thyroid function, or acromegaly) ;
- Pregnancy;
- Participated in clinical trials of other drugs within 3 months;
- In the past 5 years, there have been treated or untreated organ system tumors (exceptlocal skin basal cell carcinoma), regardless of whether there is evidence of localrecurrence or metastasis;
- A history of psychoactive substance abuse, including alcohol and a history ofalcohol-related illnesses in the past 2 years;
- The subject is allergic to the contrast agent (gadopentetate meglumine injection);
- The subject has claustrophobia;
- The subject contains metal implants that are not suitable for cardiac magneticresonance examination;
- Any conditions judged by the investigator that affect enrollment.
Study Design
Total Participants: 561
Study Start date:
February 20, 2020
Estimated Completion Date:
February 28, 2022
Study Description
Connect with a study center
Renji Hospital Department of Endocrinology and Metabolism
Shanghai, Shanghai 200127
ChinaActive - Recruiting

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