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Sponsors and Collaborators: |
New York Medical College Albert Einstein College of Medicine of Yeshiva University University of Tennessee |
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Information provided by: | New York Medical College |
ClinicalTrials.gov Identifier: | NCT00618072 |
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 rosiglitazoneone (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.
Condition | Intervention | Phase |
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Hyperinsulinemia Insulin Resistance Obesity |
Drug: metformin and rosiglitazone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance |
Estimated Enrollment: | 85 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Placebo Comparator
placebo and study diet
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Drug: metformin and rosiglitazone
4 week dosage escalation of metformin, 500 mg/day (or placebo) to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day(or placebo) added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
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B: Active Comparator
study diet plus metformin and placebo avandia
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Drug: metformin and rosiglitazone
4 week dosage escalation of metformin, 500 mg/day (or placebo) to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day(or placebo) added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
|
C: Active Comparator
study diet plus metformin and avandia
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Drug: metformin and rosiglitazone
4 week dosage escalation of metformin, 500 mg/day (or placebo) to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day(or placebo) added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
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Ages Eligible for Study: | 35 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Either:
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:
Contact: Harriette Mogul, MD MPH | 914-594-4245 | hrmogul@NYMC.edu |
Contact: Karen Tanenbaum, RN | 914-594-4245 | karen_tanenbaum@NYMC.edu |
United States, New York | |
Albert Einstein College of Medicine | Recruiting |
Bronx, New York, United States, 10461 | |
Principal Investigator: Ruth Freeman, MD | |
United States, Tennessee | |
University of Tennessee | Recruiting |
Memphis, Tennessee, United States, 38163 | |
Contact: Beverly Williams-Cleaves, MD 901-448-1053 bwilliamscle@utmem.edu |
Principal Investigator: | Harriette R Mogul, MD MPH | New York Medical College |
Responsible Party: | New York Medical College ( Harriette R. Mogul MD MPH, Director of Research, Division of Endocrinology ) |
Study ID Numbers: | GSK-109157, GSK CRN: 007674 |
Study First Received: | February 5, 2008 |
Last Updated: | February 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00618072 History of Changes |
Health Authority: | United States: Institutional Review Board |
hyperinsulinemia insulin resistance perimenopause |
obesity overweight women |
Obesity Metabolic Diseases Metformin Overweight Weight Gain Insulin Body Weight Hyperinsulinism |
Signs and Symptoms Hypoglycemic Agents Nutrition Disorders Overnutrition Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder Rosiglitazone |
Obesity Metabolic Diseases Physiological Effects of Drugs Metformin Overweight Pharmacologic Actions Insulin Body Weight |
Hyperinsulinism Signs and Symptoms Hypoglycemic Agents Nutrition Disorders Overnutrition Insulin Resistance Glucose Metabolism Disorders Rosiglitazone |