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Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

Primary Purpose

Non Alcoholic Fatty Liver Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight loss
Exercise
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Fatty Liver Disease focused on measuring NAFLD, NASH, Weight loss, Exercise, NAS scores, Mitochondrial dysfunction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

No Intervention

Arm Label

Weight loss

Exercise without weight loss

Control

Arm Description

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

24 weeks under direct supervision.

No change in usual exercise levels or food intake.

Outcomes

Primary Outcome Measures

NASH ( Non alcoholic steatohepatitis score) on liver biopsy

Secondary Outcome Measures

Liver Function Tests
ALT/AST.
DXA Scan
Ultrasonographical changes in liver echotexture

Full Information

First Posted
November 8, 2010
Last Updated
October 3, 2016
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01327443
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Fatty Liver Disease
Keywords
NAFLD, NASH, Weight loss, Exercise, NAS scores, Mitochondrial dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight loss
Arm Type
Other
Arm Description
10% weight loss in 24 weeks time period through nutritional counseling.
Arm Title
Exercise without weight loss
Arm Type
Active Comparator
Arm Description
24 weeks under direct supervision.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No change in usual exercise levels or food intake.
Intervention Type
Behavioral
Intervention Name(s)
Weight loss
Intervention Description
Nutritional counseling
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Under direct supervision
Primary Outcome Measure Information:
Title
NASH ( Non alcoholic steatohepatitis score) on liver biopsy
Time Frame
baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Liver Function Tests
Description
ALT/AST.
Time Frame
Baseline and 24 weeks
Title
DXA Scan
Time Frame
Baseline and 24 weeks
Title
Ultrasonographical changes in liver echotexture
Time Frame
Baseline and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamal Ibdah, MD; PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

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