Prader-Willi Syndrome Macronutrient Study
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 12/15/2016 |
| Start Date: | May 2014 |
| End Date: | May 2016 |
Evidence-Based Approach to Dietary Management of Prader-Willi Syndrome (PWS)
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.
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.
Inclusion Criteria:
- diagnosis of Prader Willi syndrome confirmed by chromosome analysis (ie. interstitial
deletion of paternally-derived chromosome 15q, uniparental maternal disomy or other
chromosome 15 abnormalities)
- age 5 years to 17 years
- written informed consent and assent obtained and willingness to comply with the study
schedule and procedures
- free T4, TSH values in the normal range (either endogenous or with thyroxine
replacement)
- weight stable (BMI percentile fluctuation of <5 percentiles) over the preceding 2
months prior to the study
Exclusion Criteria:
- presence of other clinically significant disease that would impact body composition
including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver
or kidney disease or neurologic disorders
- concomitant use of medications known to affect body weight or investigational drug in
the past year
We found this trial at
2
sites
2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Michael Freemark, MD
Phone: 919-684-8250
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Edmonton, Alberta T6G 2J2
Principal Investigator: Andrea M Haqq, MD
Phone: 780-492-0015
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