Non Alcoholic Fatty Liver Disease
Conditions
Keywords
NAFLD, NASH, Weight loss, Exercise, NAS scores, Mitochondrial dysfunction
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
Interventions
BEHAVIORALWeight loss
Nutritional counseling
BEHAVIORALExercise
Under direct supervision
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NASH ( Non alcoholic steatohepatitis score) on liver biopsy | baseline and 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver Function Tests | Baseline and 24 weeks | ALT/AST. |
| DXA Scan | Baseline and 24 weeks | — |
| Ultrasonographical changes in liver echotexture | Baseline and 24 weeks | — |
Countries
United States
Outcome results
None listed