EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
The goal of the study is to identify and treat women with midlife weight gain who have normal
blood sugars, but increased insulin levels (hyperinsulinemia) following the performance of a
glucose tolerance test. The study will evaluate effects of a unique carbohydrate modified
diet alone and in combination with metformin(MF) and Avandamet® (MF plus rosiglitazone (RSG))
on insulin levels in a wide range of ethnically diverse women (aged 35-55) at three academic
medical centers. The primary study hypothesis is that insulin sensitizing medications, in
combination with alterations in carbohydrate intake, will reduce insulin levels and improve
established risk factors for the metabolic syndrome.
The alarming prevalence of obesity, diabetes, and related comorbidities and the paucity of
easily adopted, cost-effective preventive strategies for high risk populations, suggest that
pharmaco-therapies and dietary regimens targeted to reducing insulin resistance could have
important clinical and public health implications.
Phase:
Phase 2
Details
Lead Sponsor:
New York Medical College
Collaborators:
Albert Einstein College of Medicine Albert Einstein College of Medicine of Yeshiva University University of Tennessee