Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT02011360
Status:
COMPLETED
Last Update Posted:
2016-12-14
First Post:
2013-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prader-Willi Syndrome Macronutrient Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011218', 'term': 'Prader-Willi Syndrome'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D000096803', 'term': 'Imprinting Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D018752', 'term': 'Diet, Fat-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-13', 'studyFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Improvement in inflammatory cytokine profile', 'timeFrame': 'During the 72 hour dietary intervention', 'description': 'The analysis will include measurements of adiponectin, GLP-1, glucose, insulin, AST, ALT, insulin sensitivity and a detailed profile ("metabolomics") of amino acids, fatty acids, acylcarnitines, and adipocytokines on the day prior to and immediately following dietary intervention.'}], 'primaryOutcomes': [{'measure': 'Suppression of ghrelin', 'timeFrame': '10 hour fast following completion of dietary intervention', 'description': 'Fasting labs will be obtained immediately following dietary intervention. These labs will include total and active ghrelin.'}], 'secondaryOutcomes': [{'measure': 'Changes in satiety', 'timeFrame': 'During the 72 hour dietary intervention', 'description': 'Changes in subjective hunger will be assessed by an appetite and hyperphagia questionnaire validated for PWS children. This will be completed by the children, with assistance of their parents, at completion of the 72 hour dietary intervention.'}, {'measure': 'Improvements in insulin sensitivity', 'timeFrame': 'During the 72 hour dietary intervention.', 'description': 'The analysis will include measurements of adiponectin, GLP-1, glucose, insulin, AST, ALT, insulin sensitivity and a detailed profile ("metabolomics") of amino acids, fatty acids, acylcarnitines, and adipocytokines on the day prior to and immediately following dietary intervention.'}]}, 'conditionsModule': {'keywords': ['Prader Willi syndrome', 'childhood obesity', 'ghrelin', 'appetite regulation'], 'conditions': ['Prader Willi Syndrome', 'Syndromic Obesity', 'Childhood Obesity']}, 'referencesModule': {'references': [{'pmid': '17636101', 'type': 'BACKGROUND', 'citation': 'Dykens EM, Maxwell MA, Pantino E, Kossler R, Roof E. Assessment of hyperphagia in Prader-Willi syndrome. Obesity (Silver Spring). 2007 Jul;15(7):1816-26. doi: 10.1038/oby.2007.216.'}, {'pmid': '17666087', 'type': 'BACKGROUND', 'citation': 'Haqq AM, Muehlbauer M, Svetkey LP, Newgard CB, Purnell JQ, Grambow SC, Freemark MS. Altered distribution of adiponectin isoforms in children with Prader-Willi syndrome (PWS): association with insulin sensitivity and circulating satiety peptide hormones. Clin Endocrinol (Oxf). 2007 Dec;67(6):944-51. doi: 10.1111/j.1365-2265.2007.02991.x. Epub 2007 Jul 30.'}, {'pmid': '20962018', 'type': 'BACKGROUND', 'citation': 'Haqq AM, Muehlbauer MJ, Newgard CB, Grambow S, Freemark M. The metabolic phenotype of Prader-Willi syndrome (PWS) in childhood: heightened insulin sensitivity relative to body mass index. J Clin Endocrinol Metab. 2011 Jan;96(1):E225-32. doi: 10.1210/jc.2010-1733. Epub 2010 Oct 20.'}, {'pmid': '12519848', 'type': 'BACKGROUND', 'citation': "Haqq AM, Farooqi IS, O'Rahilly S, Stadler DD, Rosenfeld RG, Pratt KL, LaFranchi SH, Purnell JQ. Serum ghrelin levels are inversely correlated with body mass index, age, and insulin concentrations in normal children and are markedly increased in Prader-Willi syndrome. J Clin Endocrinol Metab. 2003 Jan;88(1):174-8. doi: 10.1210/jc.2002-021052."}, {'pmid': '12091883', 'type': 'BACKGROUND', 'citation': 'Cummings DE, Clement K, Purnell JQ, Vaisse C, Foster KE, Frayo RS, Schwartz MW, Basdevant A, Weigle DS. Elevated plasma ghrelin levels in Prader Willi syndrome. Nat Med. 2002 Jul;8(7):643-4. doi: 10.1038/nm0702-643. No abstract available.'}, {'pmid': '18710462', 'type': 'BACKGROUND', 'citation': 'Haqq AM, Grambow SC, Muehlbauer M, Newgard CB, Svetkey LP, Carrel AL, Yanovski JA, Purnell JQ, Freemark M. Ghrelin concentrations in Prader-Willi syndrome (PWS) infants and children: changes during development. Clin Endocrinol (Oxf). 2008 Dec;69(6):911-20. doi: 10.1111/j.1365-2265.2008.03385.x. Epub 2008 Aug 15.'}, {'pmid': '19356713', 'type': 'BACKGROUND', 'citation': 'Newgard CB, An J, Bain JR, Muehlbauer MJ, Stevens RD, Lien LF, Haqq AM, Shah SH, Arlotto M, Slentz CA, Rochon J, Gallup D, Ilkayeva O, Wenner BR, Yancy WS Jr, Eisenson H, Musante G, Surwit RS, Millington DS, Butler MD, Svetkey LP. A branched-chain amino acid-related metabolic signature that differentiates obese and lean humans and contributes to insulin resistance. Cell Metab. 2009 Apr;9(4):311-26. doi: 10.1016/j.cmet.2009.02.002.'}, {'pmid': '21525399', 'type': 'BACKGROUND', 'citation': 'Laferrere B, Reilly D, Arias S, Swerdlow N, Gorroochurn P, Bawa B, Bose M, Teixeira J, Stevens RD, Wenner BR, Bain JR, Muehlbauer MJ, Haqq A, Lien L, Shah SH, Svetkey LP, Newgard CB. Differential metabolic impact of gastric bypass surgery versus dietary intervention in obese diabetic subjects despite identical weight loss. Sci Transl Med. 2011 Apr 27;3(80):80re2. doi: 10.1126/scitranslmed.3002043.'}, {'pmid': '21423183', 'type': 'BACKGROUND', 'citation': "Wang TJ, Larson MG, Vasan RS, Cheng S, Rhee EP, McCabe E, Lewis GD, Fox CS, Jacques PF, Fernandez C, O'Donnell CJ, Carr SA, Mootha VK, Florez JC, Souza A, Melander O, Clish CB, Gerszten RE. Metabolite profiles and the risk of developing diabetes. Nat Med. 2011 Apr;17(4):448-53. doi: 10.1038/nm.2307. Epub 2011 Mar 20."}, {'pmid': '12640371', 'type': 'BACKGROUND', 'citation': 'Sondike SB, Copperman N, Jacobson MS. Effects of a low-carbohydrate diet on weight loss and cardiovascular risk factor in overweight adolescents. J Pediatr. 2003 Mar;142(3):253-8. doi: 10.1067/mpd.2003.4.'}, {'pmid': '12761365', 'type': 'BACKGROUND', 'citation': 'Foster GD, Wyatt HR, Hill JO, McGuckin BG, Brill C, Mohammed BS, Szapary PO, Rader DJ, Edman JS, Klein S. A randomized trial of a low-carbohydrate diet for obesity. N Engl J Med. 2003 May 22;348(21):2082-90. doi: 10.1056/NEJMoa022207.'}, {'pmid': '12761364', 'type': 'BACKGROUND', 'citation': 'Samaha FF, Iqbal N, Seshadri P, Chicano KL, Daily DA, McGrory J, Williams T, Williams M, Gracely EJ, Stern L. A low-carbohydrate as compared with a low-fat diet in severe obesity. N Engl J Med. 2003 May 22;348(21):2074-81. doi: 10.1056/NEJMoa022637.'}, {'pmid': '15148064', 'type': 'BACKGROUND', 'citation': 'Stern L, Iqbal N, Seshadri P, Chicano KL, Daily DA, McGrory J, Williams M, Gracely EJ, Samaha FF. The effects of low-carbohydrate versus conventional weight loss diets in severely obese adults: one-year follow-up of a randomized trial. Ann Intern Med. 2004 May 18;140(10):778-85. doi: 10.7326/0003-4819-140-10-200405180-00007.'}, {'pmid': '12679447', 'type': 'BACKGROUND', 'citation': "Brehm BJ, Seeley RJ, Daniels SR, D'Alessio DA. A randomized trial comparing a very low carbohydrate diet and a calorie-restricted low fat diet on body weight and cardiovascular risk factors in healthy women. J Clin Endocrinol Metab. 2003 Apr;88(4):1617-23. doi: 10.1210/jc.2002-021480."}, {'pmid': '15148063', 'type': 'BACKGROUND', 'citation': 'Yancy WS Jr, Olsen MK, Guyton JR, Bakst RP, Westman EC. A low-carbohydrate, ketogenic diet versus a low-fat diet to treat obesity and hyperlipidemia: a randomized, controlled trial. Ann Intern Med. 2004 May 18;140(10):769-77. doi: 10.7326/0003-4819-140-10-200405180-00006.'}, {'pmid': '15632335', 'type': 'BACKGROUND', 'citation': 'Dansinger ML, Gleason JA, Griffith JL, Selker HP, Schaefer EJ. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial. JAMA. 2005 Jan 5;293(1):43-53. doi: 10.1001/jama.293.1.43.'}, {'pmid': '840278', 'type': 'BACKGROUND', 'citation': 'Bistrian BR, Blackburn GL, Stanbury JB. Metabolic aspects of a protein-sparing modified fast in the dietary management of Prader-Willi obesity. N Engl J Med. 1977 Apr 7;296(14):774-9. doi: 10.1056/NEJM197704072961402.'}, {'pmid': '16205463', 'type': 'BACKGROUND', 'citation': 'Fields DA, Higgins PB, Radley D. Air-displacement plethysmography: here to stay. Curr Opin Clin Nutr Metab Care. 2005 Nov;8(6):624-9. doi: 10.1097/01.mco.0000171127.44525.07.'}, {'pmid': '11369735', 'type': 'BACKGROUND', 'citation': 'Day N, McKeown N, Wong M, Welch A, Bingham S. Epidemiological assessment of diet: a comparison of a 7-day diary with a food frequency questionnaire using urinary markers of nitrogen, potassium and sodium. Int J Epidemiol. 2001 Apr;30(2):309-17. doi: 10.1093/ije/30.2.309.'}, {'pmid': '11103211', 'type': 'BACKGROUND', 'citation': 'Stubbs RJ, Hughes DA, Johnstone AM, Rowley E, Reid C, Elia M, Stratton R, Delargy H, King N, Blundell JE. The use of visual analogue scales to assess motivation to eat in human subjects: a review of their reliability and validity with an evaluation of new hand-held computerized systems for temporal tracking of appetite ratings. Br J Nutr. 2000 Oct;84(4):405-15. doi: 10.1017/s0007114500001719.'}, {'pmid': '18349056', 'type': 'BACKGROUND', 'citation': 'Liu J, Prudom CE, Nass R, Pezzoli SS, Oliveri MC, Johnson ML, Veldhuis P, Gordon DA, Howard AD, Witcher DR, Geysen HM, Gaylinn BD, Thorner MO. Novel ghrelin assays provide evidence for independent regulation of ghrelin acylation and secretion in healthy young men. J Clin Endocrinol Metab. 2008 May;93(5):1980-7. doi: 10.1210/jc.2007-2235. Epub 2008 Mar 18.'}, {'pmid': '16239128', 'type': 'BACKGROUND', 'citation': 'Haqq AM, Lien LF, Boan J, Arlotto M, Slentz CA, Muehlbauer MJ, Rochon J, Gallup D, McMahon RL, Bain JR, Stevens R, Millington D, Butler MD, Newgard CB, Svetkey LP. The Study of the Effects of Diet on Metabolism and Nutrition (STEDMAN) weight loss project: Rationale and design. Contemp Clin Trials. 2005 Dec;26(6):616-25. doi: 10.1016/j.cct.2005.09.003. Epub 2005 Oct 18.'}, {'pmid': '15271059', 'type': 'BACKGROUND', 'citation': 'Nass R, Liu J, Hellmann P, Coschigano KT, Gaylinn B, Berryman DE, Kopchick JJ, Thorner MO. Chronic changes in peripheral growth hormone levels do not affect ghrelin stomach mRNA expression and serum ghrelin levels in three transgenic mouse models. J Neuroendocrinol. 2004 Aug;16(8):669-75. doi: 10.1111/j.1365-2826.2004.01220.x.'}]}, 'descriptionModule': {'briefSummary': "The overall objective is to explore the mechanisms by which macronutrients regulate food intake and weight gain in Prader Willi Syndrome (PWS).\n\nPrevious 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* age 5 years to 17 years\n* written informed consent and assent obtained and willingness to comply with the study schedule and procedures\n* free T4, TSH values in the normal range (either endogenous or with thyroxine replacement)\n* weight stable (BMI percentile fluctuation of \\<5 percentiles) over the preceding 2 months prior to the study\n\nExclusion Criteria:\n\n* 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\n* concomitant use of medications known to affect body weight or investigational drug in the past year'}, 'identificationModule': {'nctId': 'NCT02011360', 'briefTitle': 'Prader-Willi Syndrome Macronutrient Study', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Evidence-Based Approach to Dietary Management of Prader-Willi Syndrome (PWS)', 'orgStudyIdInfo': {'id': 'Pro00049226'}, 'secondaryIdInfos': [{'id': 'SFR2382', 'type': 'OTHER_GRANT', 'domain': 'Foundation for Prader-Willi Research (US)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Low carbohydrate diet', 'description': 'Low carbohydrate diet: 15%carb; 65%fat; 20% protein. This will be administered over 72 hour hospital stay.', 'interventionNames': ['Other: Low Fat diet']}, {'type': 'OTHER', 'label': 'Low Fat diet', 'description': 'Low fat diet: 65%carb; 15%fat; 20% protein. This will be administered over a 72 hour hospital stay.', 'interventionNames': ['Other: Low Carbohydrate diet']}], 'interventions': [{'name': 'Low Carbohydrate diet', 'type': 'OTHER', 'description': 'Low carbohydrate diet: 15%carb; 65%fat; 20% protein', 'armGroupLabels': ['Low Fat diet']}, {'name': 'Low Fat diet', 'type': 'OTHER', 'description': 'Low Fat diet: 65%carb; 15%fat; 20% protein', 'armGroupLabels': ['Low carbohydrate diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Michael Freemark, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Andrea M Haqq, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation for Prader-Willi Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}