Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

Not Applicable

Completed

• Conditions: Non Alcoholic Fatty Liver Disease
• Interventions: Behavioral: Weight loss; Behavioral: Exercise

• Registration Number: NCT01327443
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

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

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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2011-03-31
• Study First Posted: 2011-04-01
• Primary Completion: 2012-09
• Study Completion: 2015-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight loss	Weight loss	10% weight loss in 24 weeks time period through nutritional counseling.
Exercise without weight loss	Exercise	24 weeks under direct supervision.

Primary Outcome Measures

Name	Time	Method
NASH ( Non alcoholic steatohepatitis score) on liver biopsy	baseline and 24 weeks

Secondary Outcome Measures

Name	Time	Method
DXA Scan	Baseline and 24 weeks
Liver Function Tests	Baseline and 24 weeks	ALT/AST.
Ultrasonographical changes in liver echotexture	Baseline and 24 weeks

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Columbia, Missouri, United States