Exercise Dose and Nonalcoholic Fatty Liver Disease (ED)

September 2, 2011 updated by: Washington University School of Medicine
The purpose of this research is to provide a better understanding of how exercise (walking) affects non-alcoholic fatty liver disease (NAFLD) in overweight people. NAFLD, which is common in obese people, occurs when the liver has too much fat.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Non-alcoholic fatty liver disease (NAFLD) affects about 33% of adults in the United States. The prevalence of NAFLD is four to five times higher in obese than lean persons and is associated with insulin resistance and the metabolic syndrome. Decreasing calorie intake and increasing physical activity has been recommended as primary therapy for NAFLD, but the independent effect of aerobic exercise is unknown. The current exercise guidelines for disease prevention and weight management range from 150 min/wk, recommended by the Centers for Disease Control and the American College of Sports Medicine, to 300 min/wk, recommended by the Institute of Medicine. However, it is not known whether aerobic exercise alone can improve NAFLD, and which recommended dose of exercise might have the most beneficial effects. The purpose of this proposal is to determine the effect of moderate intensity endurance exercise on: 1) hepatic fat content; 2) hepatic lipoprotein kinetics; and 3) plasma inflammatory markers. We hypothesize that aerobic exercise will decrease hepatic fat content, improve VLDL kinetics, and decrease inflammation in a dose-dependent fashion. The results from this study will help determine exercise guidelines for obese patients with NAFLD, and lay the groundwork for future studies evaluating the effects of exercise on metabolic diseases associated with obesity.

This proposal involves conducting a randomized controlled trial that will randomize obese subjects with NAFLD (> 10% hepatic fat content) to one of two groups: Group 1 (Control, no exercise) and Group 2 (Moderate Intensity Aerobic Exercise- 150 min/wk to 300 min/wk of supervised exercise performed at 45-55% of O2 max).

Study Type

Interventional

Enrollment (Actual)

33

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

    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-65 with Nonalcoholic Fatty Liver Disease as determined by MRS

Exclusion Criteria:

  • Medical History

    • Diabetes
    • Heart Disease
    • Asthma/Lung disease
    • Injury that prevents exercise
  • Social history

    • Drinking
    • More than one drink per day
    • Binge drinking on the weekends (more than 3 or 4 drinks per weekend day)
  • Smoking
  • It's OK if they were a previous smoker, but they need to have quit more than 6 months ago
  • Exercise

    • They must exercise less than one hour per week
    • Medications: must be on stable regimen of ANY medication for at least 3 months
  • Beta-Blockers

    • Lipid/cholesterol lowering medications:
    • Oral hypoglycemics (anti-diabetes medications - some like metformin are indicated for pre-diabetes)
  • Hormone replacement therapy
  • If the woman is pre-menopausal, it is OK if she is on birth control as long as she has been on it over 3 months
  • Weight history

    • Weight <300 lbs
    • BMI 30 to 45
    • Weight stable - <10lbs weight loss or gain in the last 3 months

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Subjects will serve as controls, continuing current diet and activity levels. Subjects will get monthly weights by the investigator at the research center.
Experimental: Exercise
For 16 weeks subjects will exercise from 30-60 minutes five times a week.
For 16 weeks subjects will exercise from 30-60 minutes five times a week.
Other Names:
  • walking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect of aerobic exercise on: Intrahepatic fat content
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
VLDL-triglyceride (TG) and VLDL-Apolipoprotein B (apoB) kinetics
Time Frame: 3 years
3 years
Insulin action in liver (suppression of glucose production), muscle (stimulation of glucose uptake), and adipose tissue (suppression of lipolysis).
Time Frame: 3 years
3 years
Plasma markers of inflammation
Time Frame: 3 years
3 years
Potential cellular mechanisms responsible for changes in insulin action and inflammation
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

May 1, 2006

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

October 9, 2008

First Submitted That Met QC Criteria

October 10, 2008

First Posted (Estimate)

October 13, 2008

Study Record Updates

Last Update Posted (Estimate)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 2, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 06-0039
  • #5P30 DK052574 (NIH/DDRCC)
  • R01 DK37948 (NIH/NIDDK)

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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