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NCT00108459 · ClinicalTrials.gov registry record · Phase 3
Low Carbohydrate Diet Compared to Calorie and Fat Restricted Diet in Patients With Obesity and Type II Diabetes
A Phase 3 study of Obesity and Type 2 Diabetes, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 156
- Enrollment target
- 1
- Study location
NCT00108459 is a Phase 3 study of Obesity and Type 2 Diabetes that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 156 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00108459, a Phase 3 study of Obesity and Type 2 Diabetes, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 156 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to address the hypothesis that in obese patients with type 2 diabetes mellitus (DM), a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over 24 months will cause 5% greater reduction in body weight in patients with obesity and type 2 DM, be safe, and will not have any detrimental effects on serum lipid concentrations.
Conditions Studied
Interventions
- BEHAVIORAL Low Carbohydrate Diet
Study Locations (1)
Pennsylvania
- VA Medical Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2004-09 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00108459
The ClinicalTrials.gov registry entry for NCT00108459 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (81% lower). The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Low Carbohydrate Diet is the first listed.
NCT00108459 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00108459 about?
NCT00108459 is a clinical study titled "Low Carbohydrate Diet Compared to Calorie and Fat Restricted Diet in Patients With Obesity and Type II Diabetes". This study is designed to address the hypothesis that in obese patients with type 2 diabetes mellitus (DM), a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over 24 months will cause 5% greater reduction in body weight in patients with obes...
What is the current status of trial NCT00108459?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 156 participants. The study started on 2004-09. Estimated completion is 2007-12.
What conditions does trial NCT00108459 study?
This clinical trial studies the following conditions: Obesity, Type 2 Diabetes, Hyperlipidemia.
What interventions are being tested in trial NCT00108459?
The interventions under investigation include: Low Carbohydrate Diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT00108459?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00108459 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.