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EMPOWIR: Enhance the Metabolic Profile of Women With Insulin Resistance: Carbohydrate Modified Diet Alone and in Combination With Metformin or Metformin Plus Avandia in Non-Diabetic Women With Midlife Weight Gain and Documented Insulin Elevations (Syndrome W)
This study is currently recruiting participants.
Verified by New York Medical College, February 2008
First Received: February 5, 2008   No Changes Posted
Sponsors and Collaborators: New York Medical College
Albert Einstein College of Medicine of Yeshiva University
University of Tennessee
Information provided by: New York Medical College
ClinicalTrials.gov Identifier: NCT00618072
  Purpose

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
Hyperinsulinemia
Insulin Resistance
Obesity
Drug: metformin and rosiglitazone
Phase II

MedlinePlus related topics: Diets Obesity
Drug Information available for: Insulin Rosiglitazone Rosiglitazone Maleate Metformin Metformin hydrochloride
U.S. FDA Resources
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

Further study details as provided by New York Medical College:

Primary Outcome Measures:
  • baseline change in fasting insulin at 6 months (placebo vs. active arms) and at 12 months (metformin vs. avandamet arms) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • baseline change in DXA-determined trunk/leg fat ratio [ Time Frame: 1 year (metformin vs. avandamet arms) ] [ Designated as safety issue: No ]

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
A: Placebo Comparator
placebo and study diet
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
B: Active Comparator
study diet plus metformin and placebo avandia
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
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

    -

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618072

Contacts
Contact: Harriette Mogul, MD MPH 914-594-4245 hrmogul@NYMC.edu
Contact: Karen Tanenbaum, RN 914-594-4245 karen_tanenbaum@NYMC.edu

Locations
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    
Sponsors and Collaborators
New York Medical College
Albert Einstein College of Medicine of Yeshiva University
University of Tennessee
Investigators
Principal Investigator: Harriette R Mogul, MD MPH New York Medical College
  More Information

Publications:
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

Keywords provided by New York Medical College:
hyperinsulinemia
insulin resistance
perimenopause
obesity
overweight
women

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009