Trials · 2013
Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Li Yan, Ma Hongli, Zhang Yuehui, Kuang Hongying, Ng Ernest Hung Yu, Hou Lihui, Wu Xiaoke
Аннотация
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.
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.
Предметные рубрики MeSH
Administration, OralAdolescentAdultBerberineBiomarkersBlood GlucoseChinaClinical ProtocolsDouble-Blind MethodFemaleGlucose Clamp TechniqueGlucose Tolerance TestHumansHypoglycemic AgentsInsulinInsulin ResistancePolycystic Ovary SyndromePredictive Value of TestsResearch DesignTreatment OutcomeYoung Adult