Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease
NCT ID: NCT01327443
Last Updated: 2016-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2010-10-31
2015-10-31
Brief Summary
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The investigators propose a randomized, controlled human clinical trial to compare the effects of aerobic exercise training (without weight loss) versus diet-induced weight loss (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH
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Detailed Description
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The investigators propose a randomized, controlled human clinical trial to compare the effects of aerobic exercise training (without weight loss) versus diet-induced weight loss (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Weight loss
10% weight loss in 24 weeks time period through nutritional counseling.
Weight loss
Nutritional counseling
Exercise without weight loss
24 weeks under direct supervision.
Exercise
Under direct supervision
Control
No change in usual exercise levels or food intake.
No interventions assigned to this group
Interventions
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Weight loss
Nutritional counseling
Exercise
Under direct supervision
Eligibility Criteria
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Inclusion Criteria
* age group 18-60 years old
* elevated Liver Function Tests (LFT's) with fatty liver on ultrasound and biopsy proven NASH
Exclusion Criteria
* evidence of other causes of hepatitis including positive screening B \& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha 1 antitrypsin deficiency or medication-induced hepatitis
* Subjects with planned exercise \> 30-60 minutes per week
* BMI \< 25 or \> 44 kg/m2
* clinical or biochemical evidence of decompensated liver disease, advanced cardiac or renal disease
* changes in last 3 months the dose of oral hypoglycemic medication and statin,
* positive stress test
* pregnant women
* demented individuals who cannot give consent
18 Years
60 Years
ALL
No
Sponsors
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University of Missouri-Columbia
OTHER
Responsible Party
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Jamal Ibdah
Principal Investigator
Principal Investigators
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Jamal Ibdah, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Locations
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University Hospital
Columbia, Missouri, United States
Countries
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Other Identifiers
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1142777
Identifier Type: -
Identifier Source: org_study_id
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