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Open Access 01-12-2013 | Study protocol

Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial

Authors: Yan Li, Hongli Ma, Yuehui Zhang, Hongying Kuang, Ernest Hung Yu Ng, Lihui Hou, Xiaoke Wu

Published in: Trials | Issue 1/2013

Abstract

Background

Insulin resistance and hyperinsulinemia play a key role in the pathogenesis of polycystic ovary syndrome (PCOS), which is characterized by hyperandrogenism, ovulatory dysfunction, and presence of polycystic ovaries on pelvic scanning. Insulin resistance is significantly associated with the long-term risks of metabolic syndrome and cardiovascular disease. Berberine has effects on insulin resistance but its use in women with PCOS has not been fully investigated. In this paper, we present a research design evaluating the effects of berberine on insulin resistance in women with PCOS.

Methods/design

This is a multicenter, randomized, placebo-controlled and double-blind trial. A total of 120 patients will be enrolled in this study and will be randomized into two groups. Berberine or placebo will be taken orally for 12 weeks. The primary outcome is the whole body insulin action assessed with the hyperinsulinemic-euglycemic clamp.

Discussion

We postulate that women with PCOS will have improved insulin resistance following berberine administration.

Trial registration

This study is registered at ClinicalTrials.gov, NCT01138930.

Available only for authorised users

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Title: Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial
Authors: Yan Li
Hongli Ma
Yuehui Zhang
Hongying Kuang
Ernest Hung Yu Ng
Lihui Hou
Xiaoke Wu
Publication date: 01-12-2013
Publisher: BioMed Central
Published in: Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/1745-6215-14-226

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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