Non Alcoholic Fatty Liver DiseaseNCT01327443
Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease
A study testing Weight loss and Exercise in people with Non Alcoholic Fatty Liver Disease, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The central hypothesis of this proposal is that a reduction in hepatic mitochondrial function is the main pathophysiology behind NAFLD (Non-Alcoholic Fatty Liver Disease) and NASH (Non alcoholic steatohepatitis). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease
- What is being tested?
- Weight loss and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- sedentary individual between
- age group 18-60 years old
- elevated Liver Function Tests (LFT's) with fatty liver on ultrasound and biopsy proven NASH
Who cannot join
- significant history of alcohol consumption > 20 gm/day (> 2 drinks / day)
- evidence of other causes of hepatitis including positive screening B \& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha 1 antitrypsin deficiency or medication-induced hepatitis
- Subjects with planned exercise > 30-60 minutes per week
- BMI < 25 or > 44 kg/m2
- clinical or biochemical evidence of decompensated liver disease, advanced cardiac or renal disease
- changes in last 3 months the dose of oral hypoglycemic medication and statin,
Show all 9Show fewer
- positive stress test
- pregnant women
- demented individuals who cannot give consent
Trial locations and contacts
1 site in 1 country.
About this study
The central hypothesis of this proposal is that a reduction in hepatic mitochondrial function is the main pathophysiology behind NAFLD (Non-Alcoholic Fatty Liver Disease) and NASH (Non alcoholic steatohepatitis). The investigators further hypothesize that lifestyle modifications through aerobic exercise training without weight loss or diet-induced weight loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content and function in human subjects.
The investigators propose a randomized, controlled human clinical trial to compare the effects of aerobic exercise training (without weight loss) versus diet-induced weight loss (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH
Read the detailed description
Fatty Liver Disease) and NASH (Non alcoholic steatohepatitis). The investigators further hypothesize that lifestyle modifications through aerobic exercise training without weight loss or diet-induced weight loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content and function in human subjects.
The investigators propose a randomized, controlled human clinical trial to compare the effects of aerobic exercise training (without weight loss) versus diet-induced weight loss (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH
- Conditions
- Non Alcoholic Fatty Liver Disease
- Being tested
- Weight loss, Exercise
- Keywords
- NAFLD, NASH, Weight loss, Exercise, NAS scores, Mitochondrial dysfunction
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Weight Loss, Motor Activity, Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossBehavioural
Nutritional counseling
ExerciseBehavioural
Under direct supervision
| Study group | Role | What they receive |
|---|---|---|
| Weight loss | Other | 10% weight loss in 24 weeks time period through nutritional counseling. Receives: Behavioral: Weight loss |
| Exercise without weight loss | Active comparator | 24 weeks under direct supervision. Receives: Behavioral: Exercise |
| Control | No intervention | No change in usual exercise levels or food intake. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NASH ( Non alcoholic steatohepatitis score) on liver biopsy
Measured: baseline and 24 weeks
Secondary outcomes (3)
Liver Function Tests
ALT/AST.
Measured: Baseline and 24 weeks
DXA Scan
Measured: Baseline and 24 weeks
Ultrasonographical changes in liver echotexture
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionSep 2012
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamal Ibdah, University of Missouri-Columbia
- Investigators
- Jamal Ibdah, MD; PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327443
- Sponsor's protocol ID
- 1142777
- Status last verified
- Oct 2016
- First submitted
- 8 Nov 2010
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT01327443
- Acronym / sponsor ID
- 1142777
- Conditions
- Non Alcoholic Fatty Liver Disease
- Keywords
- NAFLD, NASH, Weight loss, Exercise, NAS scores, Mitochondrial dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 Apr 2011 (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 central hypothesis of this proposal is that a reduction in hepatic mitochondrial function is the main pathophysiology behind NAFLD (Non-Alcoholic Fatty Liver Disease) and NASH (Non alcoholic steatohepatitis). The investigators further hypothesize that lifestyle modifications through aerobic exercise training without weight loss or diet-induced weight loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content and function in human subjects.
The investigators propose a randomized, controlled human clinical trial to compare the effects of aerobic exercise training (without weight loss) versus diet-induced weight loss (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH
Detailed description
Fatty Liver Disease) and NASH (Non alcoholic steatohepatitis). The investigators further hypothesize that lifestyle modifications through aerobic exercise training without weight loss or diet-induced weight loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content and function in human subjects.
The investigators propose a randomized, controlled human clinical trial to compare the effects of aerobic exercise training (without weight loss) versus diet-induced weight loss (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weight loss | Other | Behavioral: Weight loss10% weight loss in 24 weeks time period through nutritional counseling. |
| Exercise without weight loss | Active comparator | Behavioral: Exercise24 weeks under direct supervision. |
| Control | No intervention | –No change in usual exercise levels or food intake. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- sedentary individual between
- age group 18-60 years old
- elevated Liver Function Tests (LFT's) with fatty liver on ultrasound and biopsy proven NASH
Key exclusion criteria (9 listed)
- significant history of alcohol consumption > 20 gm/day (> 2 drinks / day)
- evidence of other causes of hepatitis including positive screening B \& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha 1 antitrypsin deficiency or medication-induced hepatitis
- Subjects with planned exercise > 30-60 minutes per week
- BMI < 25 or > 44 kg/m2
- clinical or biochemical evidence of decompensated liver disease, advanced cardiac or renal disease
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 |
|---|---|---|
| Weight lossNutritional counseling | Behavioural | Weight loss |
| ExerciseUnder direct supervision | Behavioural | Exercise without weight loss |
Primary outcome
NASH ( Non alcoholic steatohepatitis score) on liver biopsy
Time frame: baseline and 24 weeks
3 secondary outcomes
Liver Function Tests
Time frame: Baseline and 24 weeks
DXA Scan
Time frame: Baseline and 24 weeks
Ultrasonographical changes in liver echotexture
Time frame: Baseline and 24 weeks
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 5 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Jamal Ibdah, MD; PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss and Exercise in people with Non Alcoholic Fatty Liver Disease, run by University of Missouri-Columbia 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 3 inclusion and 9 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 5 Oct 2016. 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?
NASH ( Non alcoholic steatohepatitis score) on liver biopsy (time frame: baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2016.