Status:
COMPLETED
EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance
Lead Sponsor:
New York Medical College
Collaborating Sponsors:
Albert Einstein College of Medicine
University of Tennessee
Conditions:
Hyperinsulinemia
Insulin Resistance
Eligibility:
FEMALE
35-55 years
Phase:
PHASE2
Brief 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 toler...
Detailed Description
Progressive weight gain that starts in the fourth and fifth decades is commonly reported by women from all ethnic and socio-economic groups. Our previous data suggest that, in large and diverse subpop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00618072
Start Date
January 1 2008
End Date
January 1 2011
Last Update
March 28 2014
Active Locations (1)
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1
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461