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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: Completed Phase 3 study of Obesity and Type 2 Diabetes, sponsored by US Department of Veterans Affairs.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • BEHAVIORAL Low Carbohydrate Diet

Study Locations (1)

Pennsylvania

  • VA Medical Center - Philadelphia

Trial Details

FieldValue
Enrollment Target 156 participants
Start Date 2004-09
Est. Completion 2007-12
Phase Phase 3
US Department of Veterans Affairs

632 total trials

What the finished NCT00108459 record still lists

NCT00108459 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (81% lower).

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 a single indexed study location in 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.

Similar trials for Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00108459's enrollment target sits among peer trials

156 366th of 1053 higher than 687 of 1,053 other Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obesity 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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Source: ClinicalTrials.gov NCT00108459, the US trial registry maintained by the National Library of Medicine. NCT00108459 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.