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Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01327443
First Posted: April 1, 2011
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jamal Ibdah, University of Missouri-Columbia
  Purpose

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


Condition Intervention
Non Alcoholic Fatty Liver Disease Behavioral: Weight loss Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by Jamal Ibdah, University of Missouri-Columbia:

Primary Outcome Measures:
  • NASH ( Non alcoholic steatohepatitis score) on liver biopsy [ Time Frame: baseline and 24 weeks ]

Secondary Outcome Measures:
  • Liver Function Tests [ Time Frame: Baseline and 24 weeks ]
    ALT/AST.

  • DXA Scan [ Time Frame: Baseline and 24 weeks ]
  • Ultrasonographical changes in liver echotexture [ Time Frame: Baseline and 24 weeks ]

Enrollment: 17
Study Start Date: October 2010
Study Completion Date: October 2015
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Weight loss
10% weight loss in 24 weeks time period through nutritional counseling.
Behavioral: Weight loss
Nutritional counseling
Active Comparator: Exercise without weight loss
24 weeks under direct supervision.
Behavioral: Exercise
Under direct supervision
No Intervention: Control
No change in usual exercise levels or food intake.

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • sedentary individual between
  • age group 18-60 years old
  • elevated Liver Function Tests (LFT's) with fatty liver on ultrasound and biopsy proven NASH

Exclusion Criteria:

  • 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,
  • positive stress test
  • pregnant women
  • demented individuals who cannot give consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327443


Locations
United States, Missouri
University Hospital
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Jamal Ibdah, MD; PhD University of Missouri-Columbia
  More Information

Responsible Party: Jamal Ibdah, Principal Investigator, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01327443     History of Changes
Other Study ID Numbers: 1142777
First Submitted: November 8, 2010
First Posted: April 1, 2011
Last Update Posted: October 5, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jamal Ibdah, University of Missouri-Columbia:
NAFLD
NASH
Weight loss
Exercise
NAS scores
Mitochondrial dysfunction

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