Chiglitazar/Metformin in Non-obese Women With PCOS

Study Overview
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Brief Summary
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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.

Official Title
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Chiglitazar Versus Metformin for Insulin Resistance in Non-obese Patients With Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome, Chiglitazar, Metformin

Intervention / Treatment
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* Drug: Chiglitazar
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female aged 18- 45 years old Normal weight BMI 18.5--24 Diagnosis of hyperandrogenism T>0.481ng/ml The diagnosis of PCOS is based on the diagnostic criteria established by the Rotterdam consensus No use of drugs affecting reproductive endocrine in the 3 months prior to the clinic visit Exclusion Criteria: T level is within the normal range Organ dysfunction Drugs that can affect endocrine such as contraceptives and steroids taken in the past 3 months Confirmed diagnosis of diabetes 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 Have other endocrine disorders, such as thyroid dysfunction, adrenal gland disease, hyperprolactinemia, etc. Combined psychiatric disorders and severe primary diseases Allergy to the drug or components of this study Those who do not follow the doctor's instructions during the medication, or discontinue the treatment due to serious adverse reactions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chiglitazar group<br>Chiglitazar, tablet, 32mg, taken orally once daily for 3 months | Drug: Chiglitazar<br>* Chiglitazar is a novel 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.<br>|
| Active Comparator: Metformin group<br>Metformin, tablet, 0.5g, taken orally twice daily for 3 months | Drug: Metformin<br>* Metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma insulin level | Changes in insulin level before and after treatment | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total testosterone | Changes in total testosterone (TT) | Three months | 
| Sex hormone-binding globulin | Changes in sex hormone-binding globulin (SHBG) | Three months | 
| Ratio of luteinizing hormone to follicular estrogen | Changes in ratio of luteinizing hormone to follicular estrogen (LH/FSH) | Three months |