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Therapeutic Areas: Endocrinology
Disease Category: Weight Loss

Trial Information

EMPOWIR: Enhance the Metabolic Profile of Women with Insulin Resistance

Seeking Healthy Women ages 35-55

Have you gained 20 pounds or more since your 20's?
Would you like help losing those extra pounds in a healthy way?

We are looking for volunteers for a 12-month research study on weight loss.
You will receive individual and group nutritional counseling and behavior modification.
You will be given study drugs.
All volunteers will be seen monthly by a member of the treatment team.

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%
• 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

Sheila Jozak, RN, Department of Obstetrics and Gynecology and Women's Health
Einstein-Montefiore Institute for Clinical & Translational Research
3332 Rochambeau Avenue
Bronx, NY 10467
Phone: 718-405-8119
EMail: sheila.jozak@einstein.yu.edu

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