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Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

This study is currently recruiting participants.
Verified March 2011 by University of Missouri-Columbia
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01327443
First received: November 8, 2010
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • NASH ( Non alcoholic steatohepatitis score) on liver biopsy [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Liver Function Tests [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    ALT/AST.

  • DXA Scan [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Ultrasonographical changes in liver echotexture [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 105
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327443

Contacts
Contact: Abhishek Choudhary, MD 573 882 7349 choudharya@health.missouri.edu
Contact: Scott Rector, PhD 573 882 7349 rectors@health.missouri.edu

Locations
United States, Missouri
University Hospital Recruiting
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

No publications provided

Responsible Party: Jamal Ibdah, University of Missouri
ClinicalTrials.gov Identifier: NCT01327443     History of Changes
Other Study ID Numbers: 1142777
Study First Received: November 8, 2010
Last Updated: March 31, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013