Non-alcoholic Fatty Liver Disease (NAFLD)EDNCT00771108
Exercise Dose and Nonalcoholic Fatty Liver Disease
A study testing exercise in people with Non-alcoholic Fatty Liver Disease (NAFLD), run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 with Nonalcoholic Fatty Liver Disease as determined by MRS
Who cannot join
- Medical History
- Diabetes
- Heart Disease
- Asthma/Lung disease
- Injury that prevents exercise
- Social history
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the 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).
- Being tested
- exercise
- Keywords
- NAFLD, Obesity, Metabolic Syndrome, Nonalcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
Also called walking
For 16 weeks subjects will exercise from 30-60 minutes five times a week.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Subjects will serve as controls, continuing current diet and activity levels. Subjects will get monthly weights by the investigator at the research center. |
| Exercise | Experimental | For 16 weeks subjects will exercise from 30-60 minutes five times a week. Receives: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of aerobic exercise on: Intrahepatic fat content
Measured: 3 years
Secondary outcomes (4)
VLDL-triglyceride (TG) and VLDL-Apolipoprotein B (apoB) kinetics
Measured: 3 years
Insulin action in liver (suppression of glucose production), muscle (stimulation of glucose uptake), and adipose tissue (suppression of lipolysis).
Measured: 3 years
Plasma markers of inflammation
Measured: 3 years
Potential cellular mechanisms responsible for changes in insulin action and inflammation
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startMay 2006
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771108
- Sponsor's protocol ID
- 06-0039
- Other IDs
- #5P30 DK052574 (NIH/DDRCC), R01 DK37948 (NIH/NIDDK), R01DK037948, 5P30DK052574
- Acronym
- ED
- Status last verified
- Sep 2011
- First submitted
- 9 Oct 2008
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22213436
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Dose and Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT00771108
- Acronym / sponsor ID
- ED / 06-0039
- Keywords
- NAFLD, Obesity, Metabolic Syndrome, Nonalcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Subjects will serve as controls, continuing current diet and activity levels. Subjects will get monthly weights by the investigator at the research center. |
| Exercise | Experimental | Behavioral: exerciseFor 16 weeks subjects will exercise from 30-60 minutes five times a week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-65 with Nonalcoholic Fatty Liver Disease as determined by MRS
Key exclusion criteria (23 listed)
- Medical History
- Social history
- Smoking
- It's OK if they were a previous smoker, but they need to have quit more than 6 months ago
- Exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseAlso: walkingFor 16 weeks subjects will exercise from 30-60 minutes five times a week. | Behavioural | Exercise |
Primary outcome
The effect of aerobic exercise on: Intrahepatic fat content
Time frame: 3 years
4 secondary outcomes
VLDL-triglyceride (TG) and VLDL-Apolipoprotein B (apoB) kinetics
Time frame: 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
Plasma markers of inflammation
Time frame: 3 years
Potential cellular mechanisms responsible for changes in insulin action and inflammation
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
- Derived from this study: PubMed 22213436Sullivan 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.
Related trials for Non-alcoholic Fatty Liver Disease (NAFLD)
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Klein, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Non-alcoholic Fatty Liver Disease (NAFLD), run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of aerobic exercise on: Intrahepatic fat content (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00771108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011; AzTrials last refreshed its copy on 6 Nov 2026.