Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

Non Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327443
• Other study ID #: 1142777
• Status: Completed
• Phase: N/A
• First received: November 8, 2010
• Last updated: October 3, 2016
• Start date: October 2010
• Est. completion date: October 2015

Study information

• Verified date: October 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2015
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non Alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Intervention

Behavioral:
• Weight loss
Nutritional counseling
• Exercise
Under direct supervision

Locations

Country	Name	City	State
United States	University Hospital	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NASH ( Non alcoholic steatohepatitis score) on liver biopsy		baseline and 24 weeks	No
Secondary	Liver Function Tests	ALT/AST.	Baseline and 24 weeks	No
Secondary	DXA Scan		Baseline and 24 weeks	No
Secondary	Ultrasonographical changes in liver echotexture		Baseline and 24 weeks	No