Phase 2
N=46
EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance
Hyperinsulinemia · Insulin Resistance · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00618072 ↗Enrolled (actual)
46
Serious AEs
2.2%
Results posted
Mar 2014
Primary outcome: Primary: Fasting Insulin — 8.1; 8.0; 6.3 uIU/mL — p=0.181
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- metformin and rosiglitazone (Drug)
- Age
- Adult · 35+ yrs
- Sex
- Female
- Sponsor
- New York Medical College
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Insulin |
8.1; 8.0; 6.3 | 0.181 |
| SECONDARY Body Weight |
80.0; 80.4; 77.5 | 0.049 sig |
| SECONDARY HOMA-IR |
1.5; 1.6; 1.3 | 0.142 |
| SECONDARY Waist Circumference |
93.1; 90.4; 87.5 | 0.052 |
| SECONDARY Systolic BP |
113.8; 107.2; 114.2 | 0.265 |
| SECONDARY Diastolic BP |
71.7; 72.7; 74.3 | 0.025 sig |
| SECONDARY HDL |
56.5; 70.1; 68.3 | 0.016 sig |
| SECONDARY Triglycerides |
95.2; 103.1; 109.2 | 0.648 |
| SECONDARY Adiponectin |
10.6; 10.9; 18.5 | 0.092 |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00618072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.