Clinical trial NCT01327443: Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease
Official title: Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Alcoholic Fatty Liver Disease
Keywords: NAFLD
NASH
Weight loss
Exercise
NAS scores
Mitochondrial dysfunction
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2011-04-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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 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

Primary outcomes:
measure: NASH ( Non alcoholic steatohepatitis score) on liver biopsy
timeFrame: baseline and 24 weeks
Secondary outcomes:
measure: Liver Function Tests
timeFrame: Baseline and 24 weeks
measure: DXA Scan
timeFrame: Baseline and 24 weeks
measure: Ultrasonographical changes in liver echotexture
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University Hospital
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jamal Ibdah, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: