Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 1:41 PM
Study NCT ID:
NCT00771108
Status:
COMPLETED
Last Update Posted:
2011-09-07
First Post:
2008-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Dose and Nonalcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D008124', 'term': 'Locomotion'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-02', 'studyFirstSubmitDate': '2008-10-09', 'studyFirstSubmitQcDate': '2008-10-10', 'lastUpdatePostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of aerobic exercise on: Intrahepatic fat content', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'VLDL-triglyceride (TG) and VLDL-Apolipoprotein B (apoB) kinetics', 'timeFrame': '3 years'}, {'measure': 'Insulin action in liver (suppression of glucose production), muscle (stimulation of glucose uptake), and adipose tissue (suppression of lipolysis).', 'timeFrame': '3 years'}, {'measure': 'Plasma markers of inflammation', 'timeFrame': '3 years'}, {'measure': 'Potential cellular mechanisms responsible for changes in insulin action and inflammation', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NAFLD', 'Obesity', 'Metabolic Syndrome', 'Nonalcoholic Fatty Liver Disease'], 'conditions': ['Non-alcoholic Fatty Liver Disease (NAFLD)']}, 'referencesModule': {'references': [{'pmid': '22213436', 'type': 'DERIVED', 'citation': 'Sullivan S, Kirk EP, Mittendorfer B, Patterson BW, Klein S. Randomized trial of exercise effect on intrahepatic triglyceride content and lipid kinetics in nonalcoholic fatty liver disease. Hepatology. 2012 Jun;55(6):1738-45. doi: 10.1002/hep.25548. Epub 2012 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to provide a better understanding of how exercise (walking) affects non-alcoholic fatty liver disease (NAFLD) in overweight people. NAFLD, which is common in obese people, occurs when the liver has too much fat.', 'detailedDescription': 'Non-alcoholic fatty liver disease (NAFLD) affects about 33% of adults in the United States. The prevalence of NAFLD is four to five times higher in obese than lean persons and is associated with insulin resistance and the metabolic syndrome. Decreasing calorie intake and increasing physical activity has been recommended as primary therapy for NAFLD, but the independent effect of aerobic exercise is unknown. The current exercise guidelines for disease prevention and weight management range from 150 min/wk, recommended by the Centers for Disease Control and the American College of Sports Medicine, to 300 min/wk, recommended by the Institute of Medicine. However, it is not known whether aerobic exercise alone can improve NAFLD, and which recommended dose of exercise might have the most beneficial effects. The purpose of this proposal is to determine the effect of moderate intensity endurance exercise on: 1) hepatic fat content; 2) hepatic lipoprotein kinetics; and 3) plasma inflammatory markers. We hypothesize that aerobic exercise will decrease hepatic fat content, improve VLDL kinetics, and decrease inflammation in a dose-dependent fashion. The results from this study will help determine exercise guidelines for obese patients with NAFLD, and lay the groundwork for future studies evaluating the effects of exercise on metabolic diseases associated with obesity.\n\nThis proposal involves conducting a randomized controlled trial that will randomize obese subjects with NAFLD (\\> 10% hepatic fat content) to one of two groups: Group 1 (Control, no exercise) and Group 2 (Moderate Intensity Aerobic Exercise- 150 min/wk to 300 min/wk of supervised exercise performed at 45-55% of O2 max).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-65 with Nonalcoholic Fatty Liver Disease as determined by MRS\n\nExclusion Criteria:\n\n* Medical History\n\n * Diabetes\n * Heart Disease\n * Asthma/Lung disease\n * Injury that prevents exercise\n* Social history\n\n * Drinking\n * More than one drink per day\n * Binge drinking on the weekends (more than 3 or 4 drinks per weekend day)\n* Smoking\n* It's OK if they were a previous smoker, but they need to have quit more than 6 months ago\n* Exercise\n\n * They must exercise less than one hour per week\n * Medications: must be on stable regimen of ANY medication for at least 3 months\n* Beta-Blockers\n\n * Lipid/cholesterol lowering medications:\n * Oral hypoglycemics (anti-diabetes medications - some like metformin are indicated for pre-diabetes)\n* Hormone replacement therapy\n* If the woman is pre-menopausal, it is OK if she is on birth control as long as she has been on it over 3 months\n* Weight history\n\n * Weight \\<300 lbs\n * BMI 30 to 45\n * Weight stable - \\<10lbs weight loss or gain in the last 3 months"}, 'identificationModule': {'nctId': 'NCT00771108', 'acronym': 'ED', 'briefTitle': 'Exercise Dose and Nonalcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Exercise Dose and Nonalcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': '06-0039'}, 'secondaryIdInfos': [{'id': '#5P30 DK052574 (NIH/DDRCC)'}, {'id': 'R01 DK37948 (NIH/NIDDK)'}, {'id': 'R01DK037948', 'link': 'https://reporter.nih.gov/quickSearch/R01DK037948', 'type': 'NIH'}, {'id': '5P30DK052574', 'link': 'https://reporter.nih.gov/quickSearch/5P30DK052574', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Subjects will serve as controls, continuing current diet and activity levels. Subjects will get monthly weights by the investigator at the research center.'}, {'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'For 16 weeks subjects will exercise from 30-60 minutes five times a week.', 'interventionNames': ['Behavioral: exercise']}], 'interventions': [{'name': 'exercise', 'type': 'BEHAVIORAL', 'otherNames': ['walking'], 'description': 'For 16 weeks subjects will exercise from 30-60 minutes five times a week.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Samuel Klein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}