EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance

This study has been completed.
Sponsor:
Collaborators:
Albert Einstein College of Medicine of Yeshiva University
University of Tennessee
Information provided by (Responsible Party):
Harriette Mogul, New York Medical College
ClinicalTrials.gov Identifier:
NCT00618072
First received: February 5, 2008
Last updated: March 27, 2014
Last verified: March 2014
  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 rosiglitazone (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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by New York Medical College:

Primary Outcome Measures:
  • Fasting Insulin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Insulin was determined with a Siemens Immulite assay with respective intra-and inter-CV's 5.7 and 5.9%, and no cross reactivity to pro-insulin.


Secondary Outcome Measures:
  • Body Weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Body weight measurement was performed three times and averaged by a single study coordinator.

  • HOMA-IR [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    HOMA-IR was calculated by the formula: fasting insulin (uU/mL) times fasting glucose (mg/L) divided by 22.5.

  • Waist Circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Systolic BP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Blood pressure was assessed using NCEP guidelines.

  • Diastolic BP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Blood pressure was assessed using NCEP guidelines.

  • HDL [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    HDL was measured using two reagents homogeneous systems with selective detergents to homogenize the lipoprotein of interest.

  • Triglycerides [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Triglycerides were measured by enzymatic immunoassay on an AU400 chemistry auto-analyzer with commercially available enzymatic reagents.

  • Adiponectin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Total adiponectin was measured with a commercial ELISA kit (Millipore/Linco Research, St. Charles, MO) in the laboratory of Dr. Philipp Scherer.


Enrollment: 46
Study Start Date: January 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A: Study diet
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.
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
Other Names:
  • glucophage
  • avandia
  • avandamet
Active Comparator: B: Study diet plus Metformin

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.

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
Other Names:
  • glucophage
  • avandia
  • avandamet
Active Comparator: C: Study diet plus metformin and avandia

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.

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
Other Names:
  • glucophage
  • avandia
  • avandamet

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
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: Harriette Mogul, Director Research< Division of Adult Endocrinology, New York Medical College
ClinicalTrials.gov Identifier: NCT00618072     History of Changes
Other Study ID Numbers: GSK-109157, GSK CRN: 007674
Study First Received: February 5, 2008
Results First Received: January 30, 2014
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hyperinsulinism
Insulin Resistance
Obesity
Body Weight
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Insulin
Metformin
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014