Chiglitazar, Metformin, Polycystic Ovary Syndrome
Conditions
Brief summary
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, investigators applied chiglitazar and metformin to two groups of PCOS patients to understand their effects on insulin resistance.
Interventions
DRUGChiglitazar
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.
DRUGMetformin
Metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome.
Sponsors
Shengjing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma insulin level | Three months | Changes in insulin level before and after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total testosterone | Three months | Changes in total testosterone (TT) |
| Sex hormone-binding globulin | Three months | Changes in sex hormone-binding globulin (SHBG) |
| Ratio of luteinizing hormone to follicular estrogen | Three months | Changes in ratio of luteinizing hormone to follicular estrogen (LH/FSH) |
| BMI and WHtR | At baseline and at 12 weeks after randomization via a standardized protocol. | Anthropometric indices, including height, weight, waist-to-height ratio (WHtR) and BMI, were assessed at baseline and at 12 weeks after randomization via a standardized protocol. |
Countries
China
Outcome results
None listed