Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

Sponsor

University of Missouri-Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT01327443

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Fatty Liver Disease	Behavioral: Weight loss Behavioral: Exercise	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Weight loss 10% weight loss in 24 weeks time period through nutritional counseling.	Behavioral: Weight loss Nutritional counseling
Active Comparator: Exercise without weight loss 24 weeks under direct supervision.	Behavioral: Exercise Under direct supervision
No Intervention: Control No change in usual exercise levels or food intake.

Arm

Intervention/Treatment

Other: Weight loss

10% weight loss in 24 weeks time period through nutritional counseling.

Behavioral: Weight loss

Nutritional counseling

Active Comparator: Exercise without weight loss

24 weeks under direct supervision.

Behavioral: Exercise

Under direct supervision

No Intervention: Control

No change in usual exercise levels or food intake.

Outcome Measures

Primary Outcome Measures

NASH ( Non alcoholic steatohepatitis score) on liver biopsy [baseline and 24 weeks]

Secondary Outcome Measures

Liver Function Tests [Baseline and 24 weeks]
ALT/AST.
DXA Scan [Baseline and 24 weeks]
Ultrasonographical changes in liver echotexture [Baseline and 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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