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NCT02011360 · ClinicalTrials.gov registry record · NA
Prader-Willi Syndrome Macronutrient Study
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT02011360: Completed NA study, sponsored by Duke University.
NCT02011360 is a NA study that has completed, run by Duke University. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02011360, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
The overall objective is to explore the mechanisms by which macronutrients regulate food intake and weight gain in Prader Willi Syndrome (PWS). Previous studies from the investigators' labs suggest that the increased appetite of PWS may be triggered or maintained by an increase in the levels of ghrelin, an appetite-stimulating hormone produced primarily by the stomach. This study will compare the effects of low carbohydrate diet versus low fat diet on levels of ghrelin, appetite suppressing hormones and markers of insulin sensitivity in patients with PWS. The investigators hypothesize that the low carbohydrate diet will suppress plasma active ghrelin and increase appetite-suppressing hormones to a greater degree and for longer duration than the low fat diet and will thereby reduce hyperphagia and increase satiety. The investigators also hypothesize that the low carb diet will improve hormonal and metabolic markers (fatty acids, amino acids and organic acids) of insulin sensitivity and inflammatory cytokine profiles of children with PWS.
Primary Outcome
Fasting labs will be obtained immediately following dietary intervention. These labs will include total and active ghrelin.
Interventions
- OTHER Low Fat diet
- OTHER Low Carbohydrate diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-05 |
| Phase | NA |
What the finished NCT02011360 record still lists
NCT02011360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Low Fat diet is the first listed.
NCT02011360 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02011360 about?
NCT02011360 is a clinical study titled "Prader-Willi Syndrome Macronutrient Study". The overall objective is to explore the mechanisms by which macronutrients regulate food intake and weight gain in Prader Willi Syndrome (PWS). Previous studies from the investigators' labs suggest that the increased appetite of PWS may be triggered or maintained by an increase in the levels of ghr...
What is the current status of trial NCT02011360?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2014-05. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02011360?
The interventions under investigation include: Low Fat diet (OTHER), Low Carbohydrate diet (OTHER).
Who is sponsoring clinical trial NCT02011360?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02011360's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 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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