EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance (EMPOWIR)
Hyperinsulinemia, Insulin Resistance, Obesity
About this trial
This is an interventional treatment trial for Hyperinsulinemia focused on measuring hyperinsulinemia, insulin resistance, perimenopause, obesity, overweight, women
Eligibility Criteria
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.
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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
Sites / Locations
- Albert Einstein College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Active Comparator
Active Comparator
A: Study diet
B: Study diet plus Metformin
C: Study diet plus metformin and avandia
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
Metformin and Rosiglitazone Placebo EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
Metformin and Rosiglitazone EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.