Exercise Dose and Nonalcoholic Fatty Liver Disease
ED
5 other identifiers
interventional
33
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 9, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedSeptember 7, 2011
September 1, 2011
4.9 years
October 9, 2008
September 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effect of aerobic exercise on: Intrahepatic fat content
3 years
Secondary Outcomes (4)
VLDL-triglyceride (TG) and VLDL-Apolipoprotein B (apoB) kinetics
3 years
Insulin action in liver (suppression of glucose production), muscle (stimulation of glucose uptake), and adipose tissue (suppression of lipolysis).
3 years
Plasma markers of inflammation
3 years
Potential cellular mechanisms responsible for changes in insulin action and inflammation
3 years
Study Arms (2)
control
NO INTERVENTIONSubjects will serve as controls, continuing current diet and activity levels. Subjects will get monthly weights by the investigator at the research center.
Exercise
EXPERIMENTALFor 16 weeks subjects will exercise from 30-60 minutes five times a week.
Interventions
For 16 weeks subjects will exercise from 30-60 minutes five times a week.
Eligibility Criteria
You may qualify if:
- Age 18-65 with Nonalcoholic Fatty Liver Disease as determined by MRS
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
Sullivan S, Kirk EP, Mittendorfer B, Patterson BW, Klein S. Randomized trial of exercise effect on intrahepatic triglyceride content and lipid kinetics in nonalcoholic fatty liver disease. Hepatology. 2012 Jun;55(6):1738-45. doi: 10.1002/hep.25548. Epub 2012 Apr 25.
PMID: 22213436DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Klein, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2008
First Posted
October 13, 2008
Study Start
May 1, 2006
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
September 7, 2011
Record last verified: 2011-09