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OpenTrials
Completed

NCT Number: NCT01327443

Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

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

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Key information

Conditions

Non Alcoholic Fatty Liver Disease Behavior Body Weight Body Weight Changes Digestive System Diseases Fatty Liver Liver Diseases Metabolic Diseases Mitochondrial Diseases Motor Activity Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Columbia, Missouri, 65212, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight Loss

Behavioral

Nutritional counseling

Exercise

Behavioral

Under direct supervision

Primary outcomes

  1. NASH ( Non alcoholic steatohepatitis score) on liver biopsy

    Time frame: baseline and 24 weeks

Secondary outcomes

  1. Liver Function Tests

    Time frame: Baseline and 24 weeks

    ALT/AST.

  2. DXA Scan

    Time frame: Baseline and 24 weeks

  3. Ultrasonographical changes in liver echotexture

    Time frame: Baseline and 24 weeks

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2015
First posted
Apr 1, 2011
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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