Clinical trial NCT04805853: Myocardial Pathological Changes in Patients of Type 2 Diabetes With or Without PCOS Using Cardiac Magnetic Resonance
Official title: Myocardial Pathological Changes in Patients of Type 2 Diabetes With or Without PCOS Using Cardiac Magnetic Resonance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type2 Diabetes
Polycystic Ovary Syndrome
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 561
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: the change level of cardiac extracellular volume (ECV)
timeFrame: 3 years
Secondary outcomes:
measure: change in the level of troponin I (TNI)
timeFrame: 3 years
measure: change in the level of creatine kinase isoenzymes (CK-MB)
timeFrame: 3 years
measure: change in the level of Brain Natriuretic Peptide (BNP)
timeFrame: 3 years
measure: change in the level of atrialnatriureticpeptide (ANP)
timeFrame: 3 years
measure: change in the level of left ventricular ejection fraction (LVEF)
timeFrame: 3 years
measure: change in the level of left ventricular end diastolic pressure (LVEDP)
timeFrame: 3 years
measure: change in the level of output per minute (CO) in L/min
timeFrame: 3 years
measure: change in the level of left ventricular diameter reduction rate (FS)
timeFrame: 3 years
measure: Changes in score of Minnesota heart failure quality of life scale(LiHFe)
timeFrame: 3 years
measure: Changes in score of short form 12 questionnaire(SF-12)
timeFrame: 3 years
measure: Changes in score of Generalized Anxiety Disorder-7(GAD-7)
timeFrame: 3 years
measure: Changes in score of Patient Health Questionnaire-9(PHQ-9)
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital Department of Endocrinology and Metabolism
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Tao Tao, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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