Exercise Versus Diet in the Treatment of Nonalcoholic Fat... | NCT01327443

Studies
Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

NCT01327443

Sponsor

University of Missouri-Columbia

Status

Completed

Last Update Posted

Oct 5, 2016Estimated

Enrollment

17Actual

Phase

Not Applicable

Conditions

Non Alcoholic Fatty Liver Disease

Interventions

Weight loss
Exercise

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Sep 2012Actual

Completion Date

Oct 2015Actual

First Submitted Date

Nov 8, 2010

First Submission Date that Met QC Criteria

Mar 31, 2011

First Posted Date

Apr 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2016

Last Update Posted Date

Oct 5, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jamal Ibdah, Principal Investigator, University of Missouri-ColumbiaPrincipal Investigator

Lead Sponsor

University of Missouri-ColumbiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Weight loss	Other	10% weight loss in 24 weeks time period through nutritional counseling.	Behavioral: Weight loss
Exercise without weight loss	Active Comparator	24 weeks under direct supervision.	Behavioral: Exercise
Control	No Intervention	No change in usual exercise levels or food intake.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Weight loss	Behavioral	Nutritional counseling	Weight loss
Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NASH ( Non alcoholic steatohepatitis score) on liver biopsy		baseline and 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Liver Function Tests	ALT/AST.	Baseline and 24 weeks
DXA Scan		Baseline and 24 weeks
Ultrasonographical changes in liver echotexture

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jamal Ibdah, MD; PhD	University of Missouri-Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Columbia	Missouri	65212	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D015431	Weight Loss
D009043	Motor Activity
D028361	Mitochondrial Diseases

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D001836	Body Weight Changes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided