EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance (NCT00618072) | Clinical Trial Compass
CompletedPhase 2
EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance
United States46 participantsStarted 2008-01
Plain-language 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.
Who can participate
Age range35 Years – 55 Years
SexFEMALE
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Inclusion criteria
✓. Healthy, non-diabetic women with "≥20 pound weight gain since their twenties"
✓. Age: 35-55
✓. Peri-menopausal or postmenopausal status
✓. Body Mass Index (BMI) 25-35 kg/m2
✓. Either:
✓. a single blood pressure recording ≥135/85 or the use of blood pressure medication OR
✓. HDL≤50mg/dl or triglycerides ≥150 mg/dl or the use of lipid modifying medication
✓. Area-under-the-curve (AUC-)insulin level\>100mcgU/ml along with normal fasting (≤100 mg/dl) \& postprandial ((≤200 mg/dl) glucose determinations following a 75-gram standard oral glucose tolerance test.
Exclusion criteria
✕. known diabetes, fasting blood sugar ≥100 mg/dl or HbA-1-C≥6.0%