EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York Medical College
• Collaborators: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University; University of Tennessee
• Treatments: Insulin; Insulin, Globin Zinc; Metformin; Rosiglitazone

Criteria

Inclusion Criteria:

1. Healthy, non-diabetic women with "≥20 pound weight gain since their twenties"

2. Age: 35-55

3. Peri-menopausal or postmenopausal status

4. Body Mass Index (BMI) 25-35 kg/m2

5. Either:

1. a single blood pressure recording ≥135/85 or the use of blood pressure medication OR

2. HDL≤50mg/dl or triglycerides ≥150 mg/dl or the use of lipid modifying medication

6. 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.

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Exclusion Criteria:

1. known diabetes, fasting blood sugar ≥100 mg/dl or HbA-1-C≥6.0%

2. known hepatic disease or ALT>40

3. known renal disease or creatinine ≥ 1.4

4. known severe pulmonary disease

5. chronic acidosis of any etiology

6. Congestive heart failure (NYS Category 1), treated or untreated

7. Cancer - active within 5 years

8. current alcoholism or other substance abuse

9. co-morbid psychiatric disorder, which in the opinion of the screening physician would require concomitant psychotherapy as part of obesity management

10. currently untreated thyroid abnormality (TSH≤0.2 or ≥4mIU/L)

11. pregnancy or contemplation of pregnancy

12. use of TZD or metformin within the past year

13. allergy to TZD or biguanide

14. use of FDA approved or alternate obesity agent within 6 months of the study

15. history of pseudotumor cerebri

16. other impairment, such as a history of medication noncompliance, which in the judgment of the screening clinician, would preclude active study participation.

17. history of known or suspected heart disease