Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

October 3, 2016 updated by: Jamal Ibdah, University of Missouri-Columbia

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

Completed

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

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Jamal Ibdah, MD; PhD, University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

March 31, 2011

First Posted (Estimate)

April 1, 2011

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1142777

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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