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

AbstractBACKGROUND:
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.
AuthorsYan Li, Hongli Ma, Yuehui Zhang, Hongying Kuang, Ernest Hung Yu Ng, Lihui Hou, Xiaoke Wu
JournalTrials (Trials) Vol. 14 Pg. 226 (Jul 18 2013) ISSN: 1745-6215 [Electronic] England
PMID23866924 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Biomarkers
  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin
  • Berberine
Topics
  • Administration, Oral
  • Adolescent
  • Adult
  • Berberine (administration & dosage, adverse effects, therapeutic use)
  • Biomarkers (blood)
  • Blood Glucose (drug effects, metabolism)
  • China
  • Clinical Protocols
  • Double-Blind Method
  • Female
  • Glucose Clamp Technique
  • Glucose Tolerance Test
  • Humans
  • Hypoglycemic Agents (administration & dosage, adverse effects, therapeutic use)
  • Insulin (blood)
  • Insulin Resistance
  • Polycystic Ovary Syndrome (blood, diagnosis, drug therapy, physiopathology)
  • Predictive Value of Tests
  • Research Design
  • Treatment Outcome
  • Young Adult

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