Polycystic Ovary Syndrome Clinical Trial
Official title:
Chiglitazar Versus Metformin for Insulin Resistance in Non-obese Patients With Polycystic Ovary Syndrome
Verified date | November 2023 |
Source | Shengjing Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorders in women of reproductive age, and its prevalence rate is from 9% (NIH criteria) to 18% (Rotterdamcriteria). It is clinically characterized by hyperandrogenism, persistent anovulation, and polycystic ovarian changes. Moreover it is often accompanied by insulin resistance and obesity. Now, metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome. Chiglitazar is a novel peroxisome proliferation activated receptor (PPAR) agonist. Treatment of type 2 diabetes mellitus by moderate activation of PPARα, PPARγ and PPARδ, improving insulin sensitivity, regulating blood glucose, and promoting fatty acid oxidation and utilization. However, there is limited evidence for its treatment of insulin resistance in women with PCOS. Therefore, we applied chiglitazar and metformin to two groups of PCOS patients to understand their effects on insulin resistance.
Status | Enrolling by invitation |
Enrollment | 40 |
Est. completion date | May 2026 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Female aged 18- 45 years old 2. Normal weight BMI 18.5--24 3. Diagnosis of hyperandrogenism T>0.481ng/ml 4. The diagnosis of PCOS is based on the diagnostic criteria established by the Rotterdam consensus 5. No use of drugs affecting reproductive endocrine in the 3 months prior to the clinic visit Exclusion Criteria: 1. T level is within the normal range 2. Organ dysfunction 3. Drugs that can affect endocrine such as contraceptives and steroids taken in the past 3 months 4. Confirmed diagnosis of diabetes 5. Are on a diet, use weight-affecting medications, or have experienced a weight change of >4.5kg within 3 months prior to the start of the study 6. Have other endocrine disorders, such as thyroid dysfunction, adrenal gland disease, hyperprolactinemia, etc. 7. Combined psychiatric disorders and severe primary diseases 8. Allergy to the drug or components of this study 9. Those who do not follow the doctor's instructions during the medication, or discontinue the treatment due to serious adverse reactions |
Country | Name | City | State |
---|---|---|---|
China | Shengjing Hospital of China Medical University | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Shengjing Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma insulin level | Changes in insulin level before and after treatment | Three months | |
Secondary | Total testosterone | Changes in total testosterone (TT) | Three months | |
Secondary | Sex hormone-binding globulin | Changes in sex hormone-binding globulin (SHBG) | Three months | |
Secondary | Ratio of luteinizing hormone to follicular estrogen | Changes in ratio of luteinizing hormone to follicular estrogen (LH/FSH) | Three months |
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