Status:
UNKNOWN
Myocardial Pathological Changes in Patients of Type 2 Diabetes With or Without PCOS Using Cardiac Magnetic Resonance
Lead Sponsor:
RenJi Hospital
Conditions:
Type2 Diabetes
Polycystic Ovary Syndrome
Eligibility:
FEMALE
30-40 years
Brief 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 diab...
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 earlie...
Eligibility Criteria
Inclusion
- Age 30-40 years old;
- Overweight and obese women with/without type 2 diabetes without PCOS, PCOS without type 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 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;
- Willing to participate in this study and sign an informed consent form.
Exclusion
- 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;
- 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;
- 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 diabetes caused 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 (except local skin basal cell carcinoma), regardless of whether there is evidence of local recurrence or metastasis;
- A history of psychoactive substance abuse, including alcohol and a history of alcohol-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 magnetic resonance examination;
- Any conditions judged by the investigator that affect enrollment.
Key Trial Info
Start Date :
February 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2022
Estimated Enrollment :
561 Patients enrolled
Trial Details
Trial ID
NCT04805853
Start Date
February 20 2020
End Date
February 1 2022
Last Update
March 18 2021
Active Locations (1)
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1
Renji Hospital Department of Endocrinology and Metabolism
Shanghai, Shanghai Municipality, China, 200127