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NCT00473811 · ClinicalTrials.gov registry record · Phase 1
Diabetic Educational Eating Plan
A Phase 1 study, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00473811 is a Phase 1 study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 40 participants.
The verdict
NCT00473811, a Phase 1 study, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
By improving glycemic control, many of the devastating complications of diabetes are to a large extent preventable. The use of a low GI (glycemic index) diet to improve glycemic control is relatively new and untested. However, a low GI diet may be a cost-effective approach to preventing diabetes-related complications. The aim of this proposed 2-year study is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI intervention, to reduce dietary GI in patients with type 2 diabetes, and to compare it with a nutritionist-delivered standard American Diabetes Association (ADA) diet intervention. Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood lipids, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention. Primary hypotheses: 1\. Recruitment and retention rates for the low GI intervention will be satisfactory. Secondary hypotheses: 1. Participants in the low GI intervention group will show more favorable changes in physiological measures than participants in the ADA diet group. 2. Participants in the low GI group will be successful in lowering the GI of their diet. 3. Participants will find the intervention acceptable.
Interventions
- BEHAVIORAL Low GI
- BEHAVIORAL ADA diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-08 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00473811
The ClinicalTrials.gov registry entry for NCT00473811 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Worcester, which has 240 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low GI is the first listed.
NCT00473811 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00473811 about?
NCT00473811 is a clinical study titled "Diabetic Educational Eating Plan". By improving glycemic control, many of the devastating complications of diabetes are to a large extent preventable. The use of a low GI (glycemic index) diet to improve glycemic control is relatively new and untested. However, a low GI diet may be a cost-effective approach to preventing diabetes-rel...
What is the current status of trial NCT00473811?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2005-08. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00473811?
The interventions under investigation include: Low GI (BEHAVIORAL), ADA diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT00473811?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
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