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

Heilongjiang University of Chinese Medicine4 sites in 1 country120 target enrollmentJune 2010

ConditionsPolycystic Ovary Syndrome Obesity

InterventionsBerberine Placebo

DrugsBerberine Placebo

Overview

Phase: Not Applicable
Intervention: Berberine
Conditions: Polycystic Ovary Syndrome
Sponsor: Heilongjiang University of Chinese Medicine
Enrollment: 120
Locations: 4
Primary Endpoint: Whole body insulin action
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

June 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Heilongjiang University of Chinese Medicine

Responsible Party

Principal Investigator

Xiaoke Wu

Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital

Heilongjiang University of Chinese Medicine

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Berberine

Intervention: Berberine

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Whole body insulin action

Time Frame: 3 months

Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp

Secondary Outcomes

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)