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NCT00618072 · ClinicalTrials.gov registry record · Phase 2
EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance
A Phase 2 study, sponsored by New York Medical College.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT00618072: Completed Phase 2 study, sponsored by New York Medical College.
NCT00618072 is a Phase 2 study that has completed, run by New York Medical College. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00618072, a Phase 2 study, has completed, sponsored by New York Medical College.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG metformin and rosiglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2008-01 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
What the finished NCT00618072 record still lists
NCT00618072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which metformin and rosiglitazone is the first listed.
NCT00618072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00618072 about?
NCT00618072 is a clinical study titled "EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance". 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 combi...
What is the current status of trial NCT00618072?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2008-01. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00618072?
The interventions under investigation include: metformin and rosiglitazone (DRUG).
Who is sponsoring clinical trial NCT00618072?
This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00618072's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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