Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-06-18 @ 11:07 PM
Study NCT ID:
NCT02116192
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2014-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2014-04-14', 'studyFirstSubmitQcDate': '2014-04-14', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Metabolic biomarkers', 'timeFrame': '6 months', 'description': 'Including waist circumference (WC), blood pressure (BP), insulin resistance measured by homeostasis model assessment (HOMA-IR), lipids, ALT, androgens, and visceral and subcutaneous adiposity (by MR PDFF), and cardiovascular fitness (sub-maxVO2 test), in low carbohydrate/low fructose and standard weight-reduction diet groups'}, {'measure': 'PNPLA3 genotype', 'timeFrame': '6 months'}, {'measure': 'Novel free breathing hepatic MR PDFF protocol', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-alcoholic Fatty Liver Disease', 'Adolescent'], 'conditions': ['Non-alcoholic Fatty Liver Disease']}, 'referencesModule': {'references': [{'pmid': '12404244', 'type': 'BACKGROUND', 'citation': 'American Gastroenterological Association. American Gastroenterological Association medical position statement: nonalcoholic fatty liver disease. Gastroenterology. 2002 Nov;123(5):1702-4. doi: 10.1053/gast.2002.36569. No abstract available.'}, {'pmid': '18925303', 'type': 'BACKGROUND', 'citation': 'Assy N, Nasser G, Kamayse I, Nseir W, Beniashvili Z, Djibre A, Grosovski M. Soft drink consumption linked with fatty liver in the absence of traditional risk factors. Can J Gastroenterol. 2008 Oct;22(10):811-6. doi: 10.1155/2008/810961.'}, {'pmid': '15085483', 'type': 'BACKGROUND', 'citation': 'Brunt EM. Nonalcoholic steatohepatitis. Semin Liver Dis. 2004 Feb;24(1):3-20. doi: 10.1055/s-2004-823098.'}, {'pmid': '16214395', 'type': 'BACKGROUND', 'citation': 'Brunt EM. Pathology of nonalcoholic steatohepatitis. Hepatol Res. 2005 Oct;33(2):68-71. doi: 10.1016/j.hepres.2005.09.006. Epub 2005 Oct 7.'}, {'pmid': '11296694', 'type': 'BACKGROUND', 'citation': 'Chitturi S, Farrell GC. Etiopathogenesis of nonalcoholic steatohepatitis. Semin Liver Dis. 2001;21(1):27-41. doi: 10.1055/s-2001-12927.'}, {'pmid': '16540768', 'type': 'BACKGROUND', 'citation': 'Clark JM. The epidemiology of nonalcoholic fatty liver disease in adults. J Clin Gastroenterol. 2006 Mar;40 Suppl 1:S5-10. doi: 10.1097/01.mcg.0000168638.84840.ff.'}, {'pmid': '22420715', 'type': 'BACKGROUND', 'citation': 'Curtis VA, Carrel AL, Eickhoff JC, Allen DB. Gender and race influence metabolic benefits of fitness in children: a cross-sectional study. Int J Pediatr Endocrinol. 2012 Mar 15;2012(1):4. doi: 10.1186/1687-9856-2012-4.'}, {'pmid': '22999829', 'type': 'BACKGROUND', 'citation': 'Della Corte C, Alisi A, Saccari A, De Vito R, Vania A, Nobili V. Nonalcoholic fatty liver in children and adolescents: an overview. J Adolesc Health. 2012 Oct;51(4):305-12. doi: 10.1016/j.jadohealth.2012.01.010. Epub 2012 Mar 13.'}, {'pmid': '19773396', 'type': 'BACKGROUND', 'citation': 'Denzer C, Thiere D, Muche R, Koenig W, Mayer H, Kratzer W, Wabitsch M. Gender-specific prevalences of fatty liver in obese children and adolescents: roles of body fat distribution, sex steroids, and insulin resistance. J Clin Endocrinol Metab. 2009 Oct;94(10):3872-81. doi: 10.1210/jc.2009-1125. Epub 2009 Sep 22.'}, {'pmid': '19468040', 'type': 'BACKGROUND', 'citation': 'Dishman RK, Dunn AL, Sallis JF, Vandenberg RJ, Pratt CA. Social-cognitive correlates of physical activity in a multi-ethnic cohort of middle-school girls: two-year prospective study. J Pediatr Psychol. 2010 Mar;35(2):188-98. doi: 10.1093/jpepsy/jsp042. Epub 2009 May 25.'}, {'pmid': '18417045', 'type': 'BACKGROUND', 'citation': 'Dunn W, Schwimmer JB. The obesity epidemic and nonalcoholic fatty liver disease in children. Curr Gastroenterol Rep. 2008 Feb;10(1):67-72. doi: 10.1007/s11894-008-0011-1.'}, {'pmid': '19625277', 'type': 'BACKGROUND', 'citation': 'Feldstein AE, Charatcharoenwitthaya P, Treeprasertsuk S, Benson JT, Enders FB, Angulo P. The natural history of non-alcoholic fatty liver disease in children: a follow-up study for up to 20 years. Gut. 2009 Nov;58(11):1538-44. doi: 10.1136/gut.2008.171280. Epub 2009 Jul 21.'}, {'pmid': '19776184', 'type': 'BACKGROUND', 'citation': 'Kawasaki T, Igarashi K, Koeda T, Sugimoto K, Nakagawa K, Hayashi S, Yamaji R, Inui H, Fukusato T, Yamanouchi T. Rats fed fructose-enriched diets have characteristics of nonalcoholic hepatic steatosis. J Nutr. 2009 Nov;139(11):2067-71. doi: 10.3945/jn.109.105858. Epub 2009 Sep 23.'}, {'pmid': '19637286', 'type': 'BACKGROUND', 'citation': 'Loomba R, Sirlin CB, Schwimmer JB, Lavine JE. Advances in pediatric nonalcoholic fatty liver disease. Hepatology. 2009 Oct;50(4):1282-93. doi: 10.1002/hep.23119.'}, {'pmid': '7382552', 'type': 'BACKGROUND', 'citation': 'Ludwig J, Viggiano TR, McGill DB, Oh BJ. Nonalcoholic steatohepatitis: Mayo Clinic experiences with a hitherto unnamed disease. Mayo Clin Proc. 1980 Jul;55(7):434-8.'}, {'pmid': '20012810', 'type': 'BACKGROUND', 'citation': "Lytle LA, Murray DM, Evenson KR, Moody J, Pratt CA, Metcalfe L, Parra-Medina D. Mediators affecting girls' levels of physical activity outside of school: findings from the trial of activity in adolescent girls. Ann Behav Med. 2009 Oct;38(2):124-36. doi: 10.1007/s12160-009-9127-2. Epub 2009 Dec 12."}, {'pmid': '15331061', 'type': 'BACKGROUND', 'citation': 'McCullough AJ. The clinical features, diagnosis and natural history of nonalcoholic fatty liver disease. Clin Liver Dis. 2004 Aug;8(3):521-33, viii. doi: 10.1016/j.cld.2004.04.004.'}, {'pmid': '8286993', 'type': 'BACKGROUND', 'citation': 'Miller WR. What really drives change? Addiction. 1993 Nov;88(11):1479-80. doi: 10.1111/j.1360-0443.1993.tb03133.x. No abstract available.'}, {'pmid': '22129639', 'type': 'BACKGROUND', 'citation': 'Nomura K, Yamanouchi T. The role of fructose-enriched diets in mechanisms of nonalcoholic fatty liver disease. J Nutr Biochem. 2012 Mar;23(3):203-8. doi: 10.1016/j.jnutbio.2011.09.006. Epub 2011 Nov 29.'}, {'pmid': '8213605', 'type': 'BACKGROUND', 'citation': 'Park YK, Yetley EA. Intakes and food sources of fructose in the United States. Am J Clin Nutr. 1993 Nov;58(5 Suppl):737S-747S. doi: 10.1093/ajcn/58.5.737S.'}, {'pmid': '20562718', 'type': 'BACKGROUND', 'citation': 'Pozzato C, Verduci E, Scaglioni S, Radaelli G, Salvioni M, Rovere A, Cornalba G, Riva E, Giovannini M. Liver fat change in obese children after a 1-year nutrition-behavior intervention. J Pediatr Gastroenterol Nutr. 2010 Sep;51(3):331-5. doi: 10.1097/MPG.0b013e3181d70468.'}, {'pmid': '12657338', 'type': 'BACKGROUND', 'citation': 'Sallis JF, McKenzie TL, Conway TL, Elder JP, Prochaska JJ, Brown M, Zive MM, Marshall SJ, Alcaraz JE. Environmental interventions for eating and physical activity: a randomized controlled trial in middle schools. Am J Prev Med. 2003 Apr;24(3):209-17. doi: 10.1016/s0749-3797(02)00646-3.'}, {'pmid': '17682977', 'type': 'BACKGROUND', 'citation': 'Schwimmer JB. Definitive diagnosis and assessment of risk for nonalcoholic fatty liver disease in children and adolescents. Semin Liver Dis. 2007 Aug;27(3):312-8. doi: 10.1055/s-2007-985075.'}, {'pmid': '15339742', 'type': 'BACKGROUND', 'citation': 'Szczepaniak LS, Nurenberg P, Leonard D, Browning JD, Reingold JS, Grundy S, Hobbs HH, Dobbins RL. Magnetic resonance spectroscopy to measure hepatic triglyceride content: prevalence of hepatic steatosis in the general population. Am J Physiol Endocrinol Metab. 2005 Feb;288(2):E462-8. doi: 10.1152/ajpendo.00064.2004. Epub 2004 Aug 31.'}, {'pmid': '23238855', 'type': 'BACKGROUND', 'citation': 'Williams KH, Shackel NA, Gorrell MD, McLennan SV, Twigg SM. Diabetes and nonalcoholic Fatty liver disease: a pathogenic duo. Endocr Rev. 2013 Feb;34(1):84-129. doi: 10.1210/er.2012-1009. Epub 2012 Dec 13.'}]}, 'descriptionModule': {'briefSummary': 'This research study intends to learn about whether early intervention can help to prevent non-alcoholic fatty liver disease (NAFLD) in adolescents. Potentially eligible adolescents who are seen at the University of Wisconsin (UW) Pediatric Fitness Clinic will be asked to join the study. Patients who agree to participate in the study will be randomized into either the intervention group or the control group. The intervention group will follow a low-fructose diet. In addition, participants will be asked to return to the clinic for 4 follow-up visits during a 6-month interval.', 'detailedDescription': 'This will be a prospective, randomized, controlled trial for obese adolescents. Sixty obese youth (male and female), age 11-17 years with BMI \\>95 %tile for age and sex and one parent/guardian will be recruited for inclusion into the study at an initial pediatric fitness clinic visit. Consented subjects will be stratified by gender and ethnicity and randomized into low fructose or standard weight loss dietary intervention groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 11-17 years of age\n* BMI \\>95%tile for age and sex\n* Being seen for an initial clinic visit at the UW Pediatric Fitness Clinic\n* Parent willing to participate in study\n\nExclusion Criteria:\n\n* History of chronic disease that effects hepatic or renal function including: Type 1 or Type 2 diabetes mellitus, known liver disease or other chronic illness.'}, 'identificationModule': {'nctId': 'NCT02116192', 'acronym': 'NAFLD', 'briefTitle': 'Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents', 'orgStudyIdInfo': {'id': 'K12HD055894', 'link': 'https://reporter.nih.gov/quickSearch/K12HD055894', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'General Healthy Diet', 'description': 'Control: General Healthy Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat)', 'interventionNames': ['Behavioral: General Healthy Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Low-fructose, reduced carbohydrate diet', 'description': 'Intervention: Low Carbohydrate (Low Fructose and Sucrose) Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg;40-45% CHO, 20-25% Protein, 30-40% Fat)\n\n● Aim for less than 25g fructose daily.', 'interventionNames': ['Behavioral: Experimental: Low-fructose, reduced carbohydrate diet']}], 'interventions': [{'name': 'Experimental: Low-fructose, reduced carbohydrate diet', 'type': 'BEHAVIORAL', 'description': 'Low Carbohydrate (Low Fructose and Sucrose) Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg;40-45% CHO, 20-25% Protein, 30-40% Fat)\n\n● Aim for less than 25g fructose daily.', 'armGroupLabels': ['Low-fructose, reduced carbohydrate diet']}, {'name': 'General Healthy Diet', 'type': 'BEHAVIORAL', 'description': 'Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat', 'armGroupLabels': ['General Healthy Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53711', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Research Park Clinic', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Jennifer Rehm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}