Exercise Dose and Nonalcoholic Fatty Liver Disease

Non-alcoholic Fatty Liver Disease (NAFLD) Clinical Trial

— ED  

Official title:

Exercise Dose and Nonalcoholic Fatty Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771108
• Other study ID #: 06-0039
• Secondary ID: #5P30 DK052574 (
• Status: Completed
• Phase: N/A
• First received: October 9, 2008
• Last updated: September 2, 2011
• Start date: May 2006
• Est. completion date: April 2011

Study information

• Verified date: September 2011
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease (NAFLD)

Intervention

Behavioral:
• exercise
For 16 weeks subjects will exercise from 30-60 minutes five times a week.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of aerobic exercise on: Intrahepatic fat content		3 years	No
Secondary	VLDL-triglyceride (TG) and VLDL-Apolipoprotein B (apoB) kinetics		3 years	No
Secondary	Insulin action in liver (suppression of glucose production), muscle (stimulation of glucose uptake), and adipose tissue (suppression of lipolysis).		3 years	No
Secondary	Plasma markers of inflammation		3 years	No
Secondary	Potential cellular mechanisms responsible for changes in insulin action and inflammation		3 years	No