title: Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial.
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
  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.
  
  
  CONCLUSIONS
  We postulate that women with PCOS will have improved insulin resistance following berberine administration.
  
  
  BACKGROUND
  This study is registered at ClinicalTrials.gov, NCT01138930.
authors.affiliation: Department of Obstetrics and Gynecology, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin 150040, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Li
authors.forename: Hongli
authors.initials: H
authors.lastname: Ma
authors.forename: Yuehui
authors.initials: Y
authors.lastname: Zhang
authors.forename: Hongying
authors.initials: H
authors.lastname: Kuang
authors.forename: Ernest Hung Yu
authors.initials: EH
authors.lastname: Ng
authors.forename: Lihui
authors.initials: L
authors.lastname: Hou
authors.forename: Xiaoke
authors.initials: X
authors.lastname: Wu
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001599:Berberine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D002681:China; D002985:Clinical Protocols; D004311:Double-Blind Method; D005260:Female; D015309:Glucose Clamp Technique; D005951:Glucose Tolerance Test; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000097:blood*; D007333:Insulin Resistance; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D011237:Predictive Value of Tests; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D001599:Berberine