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Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Missouri-Columbia.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014