Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

University of Missouri (MU)

Status: Completed

Conditions: Non Alcoholic Fatty Liver Disease

Treatments: Behavioral: Weight loss; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01327443

1142777

Details and patient eligibility

About

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

Full 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

Enrollment: 17 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 3 patient groups

Weight loss

Other group

Description:

10% weight loss in 24 weeks time period through nutritional counseling.

Treatment:

Behavioral: Weight loss

Exercise without weight loss

Active Comparator group

Description:

24 weeks under direct supervision.

Treatment:

Behavioral: Exercise

Control

No Intervention group

Description:

No change in usual exercise levels or food intake.