NCT01327443

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

November 8, 2010

Last Update Submit

October 3, 2016

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

NAFLDNASHWeight lossExerciseNAS scoresMitochondrial dysfunction

Outcome Measures

Primary Outcomes (1)

  • NASH ( Non alcoholic steatohepatitis score) on liver biopsy

    baseline and 24 weeks

Secondary Outcomes (3)

  • Liver Function Tests

    Baseline and 24 weeks

  • DXA Scan

    Baseline and 24 weeks

  • Ultrasonographical changes in liver echotexture

    Baseline and 24 weeks

Study Arms (3)

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

Weight lossBEHAVIORAL

Nutritional counseling

Weight loss
ExerciseBEHAVIORAL

Under direct supervision

Exercise without weight loss

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • sedentary individual between
  • age group 18-60 years old
  • elevated Liver Function Tests (LFT's) with fatty liver on ultrasound and biopsy proven NASH

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseWeight LossMotor ActivityMitochondrial Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jamal Ibdah, MD; PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2010

First Posted

April 1, 2011

Study Start

October 1, 2010

Primary Completion

September 1, 2012

Study Completion

October 1, 2015

Last Updated

October 5, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)