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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 is a NA study that has completed, run by Duke University. The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02011360
The ClinicalTrials.gov registry entry for NCT02011360 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low Fat diet is the first listed.
NCT02011360 reports 0 study locations.
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.
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