EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperinsulinemia, Insulin Resistance, Obesity

In brief

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.

Key facts

Study ID

NCT00618072

Run by

New York Medical College

People needed

46

Starts

2008-01-01

Expected to finish

2011-01-01

Last updated by the study team

2014-03-28

Who can join

Age: 35 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• known diabetes, fasting blood sugar ≥100 mg/dl or HbA-1-C≥6.0%
• known hepatic disease or ALT>40
• known renal disease or creatinine ≥ 1.4
• known severe pulmonary disease
• chronic acidosis of any etiology
• Congestive heart failure (NYS Category 1), treated or untreated
• Cancer - active within 5 years
• current alcoholism or other substance abuse
• co-morbid psychiatric disorder, which in the opinion of the screening physician would require concomitant psychotherapy as part of obesity management
• currently untreated thyroid abnormality (TSH≤0.2 or ≥4mIU/L)
• pregnancy or contemplation of pregnancy
• use of TZD or metformin within the past year
• allergy to TZD or biguanide
• use of FDA approved or alternate obesity agent within 6 months of the study
• history of pseudotumor cerebri
• other impairment, such as a history of medication noncompliance, which in the judgment of the screening clinician, would preclude active study participation.
• history of known or suspected heart disease

Where it is running

• Albert Einstein College of Medicine — The Bronx, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.