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Exercise Dose and Nonalcoholic Fatty Liver Disease (ED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00771108
First received: October 9, 2008
Last updated: September 2, 2011
Last verified: September 2011
History of Changes
  Purpose
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.

Condition Intervention
Non-alcoholic Fatty Liver Disease (NAFLD)
 Behavioral: exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Exercise Dose and Nonalcoholic Fatty Liver Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The effect of aerobic exercise on: Intrahepatic fat content [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VLDL-triglyceride (TG) and VLDL-Apolipoprotein B (apoB) kinetics [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Insulin action in liver (suppression of glucose production), muscle (stimulation of glucose uptake), and adipose tissue (suppression of lipolysis). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Plasma markers of inflammation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Potential cellular mechanisms responsible for changes in insulin action and inflammation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Enrollment: 33
Study Start Date: May 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Behavioral: exercise
For 16 weeks subjects will exercise from 30-60 minutes five times a week.
Other Name: walking

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).

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771108

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Samuel Klein, MD Washington University School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00771108     History of Changes
Other Study ID Numbers: 06-0039  #5P30 DK052574 (NIH/DDRCC)  R01DK037948 
Study First Received: October 9, 2008
Last Updated: September 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
NAFLD
Obesity
Metabolic Syndrome
Nonalcoholic Fatty Liver Disease

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases

ClinicalTrials.gov processed this record on September 23, 2016