Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)

Study Overview
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Brief Summary
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Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and hormonal parameters and insulin resistance in obese patients with PCOS.

Official Title
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Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS

Conditions
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Polycystic Ovary Syndrome, Obesity

Intervention / Treatment
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* Drug: Berberine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age of women between 18 and 35 years. Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandrogenism. Body mass index (BMI) equal to or greater than 23 kg/m2. With no desire of children within 6 month. PCOS is defined by the modified Rotterdam criteria: oligomenorrhea or amenorrhea, together with presence of ≥12 antral follicles (≤9mm) and/or ovarian volume >10 ml on transvaginal scanning, and/or clinical/biochemical hyperandrogenism. Oligomenorrhea is defined as an intermenstrual interval >35 days and <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days. Clinical hyperandrogenism in China Mainland is defined as a Ferriman-Gallwey (FG) score ≥5. Exclusion criteria are Use of hormonal drugs or other medications including Chinese Herbal prescriptions in the past 3 months. Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome Patients with known sever organ dysfunction or mental illness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Berberine<br> | Drug: Berberine<br>* 1.5g daily for 3 month<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole body insulin action | Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral glucose tolerance test (OGTT) |  | 3 months | 
| Ovarian androgen biosynthesis |  | 3 months | 
| Hormonal profile |  | 3 months | 
| Fasting lipid metabolic profile |  | 3 months | 
| Renal and liver function tests |  | 3 months | 
| Adverse events |  | 3 months | 
| 6) Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment. |  | Three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome, Obesity