- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01327443
Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease
The central hypothesis of this proposal is that a reduction in hepatic mitochondrial function is the main pathophysiology behind NAFLD (Non-Alcoholic Fatty Liver Disease) and NASH (Non alcoholic steatohepatitis). The investigators further hypothesize that lifestyle modifications through aerobic exercise training without weight loss or diet-induced weight loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content and function in human subjects.
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Fatty Liver Disease) and NASH (Non alcoholic steatohepatitis). The investigators further hypothesize that lifestyle modifications through aerobic exercise training without weight loss or diet-induced weight loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content and function in human subjects.
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- sedentary individual between
- age group 18-60 years old
- elevated Liver Function Tests (LFT's) with fatty liver on ultrasound and biopsy proven NASH
Exclusion Criteria:
- significant history of alcohol consumption > 20 gm/day (> 2 drinks / day)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Weight loss
10% weight loss in 24 weeks time period through nutritional counseling.
|
Nutritional counseling
|
Active Comparator: Exercise without weight loss
24 weeks under direct supervision.
|
Under direct supervision
|
No Intervention: Control
No change in usual exercise levels or food intake.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
NASH ( Non alcoholic steatohepatitis score) on liver biopsy
Time Frame: baseline and 24 weeks
|
baseline and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Liver Function Tests
Time Frame: Baseline and 24 weeks
|
ALT/AST.
|
Baseline and 24 weeks
|
DXA Scan
Time Frame: Baseline and 24 weeks
|
Baseline and 24 weeks
|
|
Ultrasonographical changes in liver echotexture
Time Frame: Baseline and 24 weeks
|
Baseline and 24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jamal Ibdah, MD; PhD, University of Missouri-Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1142777
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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