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NCT01729117 · ClinicalTrials.gov registry record · NA
A Trial of Meal Replacement at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population
A NA study, sponsored by University of Southern California.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01729117: Completed NA study, sponsored by University of Southern California.
NCT01729117 is a NA study that has completed, run by University of Southern California. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01729117, a NA study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Background and Rationale Research studies have shown that patients with type 2 diabetes (T2DM) who lose weight have better glucose control and less risk for heart disease. It has been difficult to achieve these results in a non-research setting. Meal replacements (MR) are pre-packaged meals with appropriate calories and nutrients that enhance adherence to a weight loss program by reducing decision-making and facilitating target caloric intake. The University of Southern California (USC) arm of the NIH funded Look AHEAD study at Roybal Clinic has demonstrated acceptability and success of MRs in conjunction with a structured lifestyle modification program in achieving weight loss in underserved Hispanic T2DM patients. Objectives Our short-term objective is to determine the efficacy, safety and feasibility of a 3-month full MR program in conjunction with a 1 year standardized lifestyle modification program in a clinic setting. Our longer-term goal is to acquire data for sample size and power estimates for a larger NIH- or other funded prospective, randomized trial. Study Methodology A 1-year, prospective trial study of 30 obese subjects with T2DM treated with insulin randomized to 2 groups: standard care (SC) or Meal Replacement group (MR). The SC will receive usual care at Roybal Diabetes Management Clinic (DMC). The MR will receive MRs and a lifestyle course in addition to the usual clinical care at the Roybal DMC. Phase 1 consists of 3-months 1200 -1400cal diet using full MR. Phase 2 consists of a 3-month transition to the same caloric intake using regular meals and 1 MR/day . Phase 3 consists of a 6-month weight loss maintenance period with 1 MR/day. This will be about 1400-1600 calories/day for women and 1800 to 2000 calories/day for men. Individual and group educational, support and counseling visits will be components of all 3 phases of the study. Outcomes Efficacy of the program will be determined by weight, waist measurement and waist to hip ratio, blood pr
Interventions
- OTHER Standard Care
- OTHER Meal Replacement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-05 |
| Est. Completion | 2012-04 |
| Phase | NA |
What the finished NCT01729117 record still lists
NCT01729117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT01729117 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01729117 about?
NCT01729117 is a clinical study titled "A Trial of Meal Replacement at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population". Background and Rationale Research studies have shown that patients with type 2 diabetes (T2DM) who lose weight have better glucose control and less risk for heart disease. It has been difficult to achieve these results in a non-research setting. Meal replacements (MR) are pre-packaged meals with app...
What is the current status of trial NCT01729117?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2009-05. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01729117?
The interventions under investigation include: Standard Care (OTHER), Meal Replacement (OTHER).
Who is sponsoring clinical trial NCT01729117?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01729117's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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