- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00771108
Exercise Dose and Nonalcoholic Fatty Liver Disease (ED)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Experimental: Exercise
For 16 weeks subjects will exercise from 30-60 minutes five times a week.
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For 16 weeks subjects will exercise from 30-60 minutes five times a week.
Other Names:
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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
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Insulin action in liver (suppression of glucose production), muscle (stimulation of glucose uptake), and adipose tissue (suppression of lipolysis).
Time Frame: 3 years
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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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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-
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