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
Results First Received: January 30, 2014  
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
Conditions: Hyperinsulinemia
Insulin Resistance
Obesity
Intervention: Drug: metformin and rosiglitazone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled from December 2007 until November 2010. The study was conducted at two academic medical centers: Montefiore Hospital/Einstein, Bronx, and Westchester Medical Center/New York Medical College, Valhalla, NY in conjunction with the GCRC at Einstein.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, subjects attended 4 weekly workshops to introduce study instruments & the EMPOWIR diet -a food exchange program promoting intake of vegetables, low-glycemic index fruits, low-fat protein & dairy products, elimination of added sugars & the notable restriction of 3 additional allowable carbohydrates to after 4PM.

Reporting Groups
  Description
A: EMPOWIR Diet and Placebo 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.
B: EMPOWIR Diet Plus Metformin and Placebo Avandia 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.
C: EMPOWIR 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 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.

Participant Flow:   Overall Study
    A: EMPOWIR Diet and Placebo     B: EMPOWIR Diet Plus Metformin and Placebo Avandia     C: EMPOWIR Diet Plus Metformin and Avandia  
STARTED     16     15     15  
COMPLETED     14     14     11  
NOT COMPLETED     2     1     4  
Lost to Follow-up                 2                 0                 3  
Physician Decision                 0                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
A: EMPOWIR Diet and Placebo 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
B: EMPOWIR Diet Plus Metformin and Placebo Avandia 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
C: EMPOWIR 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 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
Total Total of all reporting groups

Baseline Measures
    A: EMPOWIR Diet and Placebo     B: EMPOWIR Diet Plus Metformin and Placebo Avandia     C: EMPOWIR Diet Plus Metformin and Avandia     Total  
Number of Participants  
[units: participants]
  16     15     15     46  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     16     15     15     46  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     16     15     15     46  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     16     15     15     46  
Fasting insulin  
[units: uIU/mL]
Mean ± Standard Deviation
  11.2  ± 1.4     12.5  ± 2.0     8.7  ± 1.5     10.7  ± 0.7  
Body Weight  
[units: kg]
Mean ± Standard Deviation
  84.1  ± 2.8     85.1  ± 2.4     81.8  ± 3.2     82.4  ± 1.63  
HOMA-IR  
[units: HOMA-IR┬áscore]
Mean ± Standard Deviation
  2.3  ± 0.2     2.5  ± 0.4     1.9  ± 0.3     2.3  ± 0.2  
Waist circumference  
[units: cm]
Mean ± Standard Deviation
  97.5  ± 2.3     92.9  ± 1.8     93.1  ± 2.1     94.7  ± 1.27  
Systolic BP  
[units: mmHg]
Mean ± Standard Deviation
  117.5  ± 2.9     114.3  ± 3.4     118.7  ± 6.0     118.2  ± 2.1  
Diastolic BP  
[units: mmHg]
Mean ± Standard Deviation
  75.9  ± 2.6     75.3  ± 2.0     76.9  ± 4.2     75.4  ± 1.4  
HDL  
[units: mg/dl]
Mean ± Standard Deviation
  49.3  ± 2.3     61.6  ± 5.7     60.1  ± 3.2     58.9  ± 2.4  
Triglycerides  
[units: mg/dl]
Mean ± Standard Deviation
  90.1  ± 9.5     88.0  ± 11.3     82.6  ± 11.2     86.9  ± 9.3  
Adiponectin  
[units: ug/mL]
Mean ± Standard Deviation
  9.3  ± 1.3     10.6  ± 1.4     11.1  ± 1.0     10.6  ± 4.6  



  Outcome Measures
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1.  Primary:   Fasting Insulin   [ Time Frame: 6 months ]

2.  Secondary:   Body Weight   [ Time Frame: 6 months ]

3.  Secondary:   HOMA-IR   [ Time Frame: 6 months ]

4.  Secondary:   Waist Circumference   [ Time Frame: 6 months ]

5.  Secondary:   Systolic BP   [ Time Frame: 6 months ]

6.  Secondary:   Diastolic BP   [ Time Frame: 6 months ]

7.  Secondary:   HDL   [ Time Frame: 6 months ]

8.  Secondary:   Triglycerides   [ Time Frame: 6 months ]

9.  Secondary:   Adiponectin   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Widespread media coverage of cardiovascular risks of rosiglitazone led to an unanticipated high drop out rate of subjects just prior to their randomization; 22 of 68 eligible subjects did not undergo randomization due to concerns about the drug.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Harriette R. Mogul MD MPH
Organization: New York Medical College
phone: 914-594-2278
e-mail: Harriette_Mogul@NYMC.edu


Publications:

Responsible Party: Harriette Mogul, 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