NCT02181270

Brief Summary

Individuals with obesity and particular type 2 diabetes have abnormally high levels of fat in liver cells and are at increased risk for cardiovascular and liver-related mortality. Prior research has shown that caloric restriction, exercise, and behavior modification can help lower hepatic fat levels in these individuals. Additional research has also shown that exercise independent of weight loss can reduce hepatic fat content in obese humans. The current exercise guidelines do not specify what type or what intensity of exercise is required to induce such reductions in hepatic fat. Thus, the purpose for doing this study is to determine if there are differential effects on liver fat with 4 wk of high intensity intermittent exercise compared with continuous moderate exercise in obese individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

3.7 years

First QC Date

June 30, 2014

Last Update Submit

January 20, 2018

Conditions

Keywords

NAFLDobesityck18blood lipidshigh intensity exercise trainingindividuals>5% liver fat

Outcome Measures

Primary Outcomes (1)

  • percent of intrahepatic fat as measured by magnetic resonance spectroscopy

    6 weeks

Secondary Outcomes (1)

  • plasma cytokeratin 18 (ck18) units: (U/I)

    6 weeks

Other Outcomes (1)

  • blood measures of blood lipids (triglycerides, cholesterol, high density lipoproteins (HDL) )

    6 weeks

Study Arms (2)

high intensity exercise

EXPERIMENTAL

High-intensity interval exercise (HIIE): Subjects will perform 5-10 minute warm-up (50% VO2peak). Subjects will then exercise at an exercise intensity that corresponds to 90% HRmax, for 4 minutes. This will be followed by 3 min of exercise at 55% HRmax. Four of these exercise intervals/recovery periods will be completed. The total exercise commitment will be \~45 minutes

Other: high intensity exercise

Continuous moderate exercise group

EXPERIMENTAL

Continuous moderate exercise group (CME): Subjects will perform a 5-10 minute warm-up at 50% VO2peak. Thereafter, the intensity of exercise will be increased to 70% VO2peak by increasing the speed and incline of the treadmill. Subjects will exercise at this intensity for 60 minutes.

Other: continuous moderate exercise

Interventions

Subjects will perform 5-10 minute warm-up (50% VO2peak). Subjects will then exercise at an exercise intensity that corresponds to 90% HRmax, for 4 minutes. This will be followed by 3 min of exercise at 55% HRmax. Four of these exercise intervals/recovery periods will be completed. The total exercise commitment will be \~45 minutes

high intensity exercise

Subjects will perform a 5-10 minute warm-up at 50% VO2peak. Thereafter, the intensity of exercise will be increased to 70% VO2peak by increasing the speed and incline of the treadmill. Subjects will exercise at this intensity for 60 minutes.

Continuous moderate exercise group

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Overweight or obese with a body mass index between 30-45 kg/m2.
  • No known cardiovascular, kidney, or liver disease.
  • No extreme hypertension (\>160 mm Hg systolic and/or \> 100 mm Hg diastolic).
  • Not being treated with exogenous insulin.
  • No history of surgery for weight loss and weight stable for prior 3 months (weight change \< 3 kg).
  • Non-exerciser (\< 20 minutes of exercise 2 days per week).
  • Between 21-60 yr of age

You may not qualify if:

  • History of alcohol use (\> 20 g/day for males and \> 10 g/day for females)
  • Kidney or liver disease.
  • Extreme hypertension \>160 mm Hg systolic and/or \> 100 mm Hg diastolic.
  • Waist measurement greater than 60"
  • Magnetic Resonance Spectroscopy scan with less than 5% of liver fat
  • A history of surgery for weight loss.
  • Exerciser (\>20 minutes of exercise at least 2 days per week)
  • Pregnant or lactating
  • \<21 or \>60 yr of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Related Publications (1)

  • Winn NC, Liu Y, Rector RS, Parks EJ, Ibdah JA, Kanaley JA. Energy-matched moderate and high intensity exercise training improves nonalcoholic fatty liver disease risk independent of changes in body mass or abdominal adiposity - A randomized trial. Metabolism. 2018 Jan;78:128-140. doi: 10.1016/j.metabol.2017.08.012. Epub 2017 Sep 20.

MeSH Terms

Conditions

ObesityNon-alcoholic Fatty Liver Disease

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jill Kanaley, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 3, 2014

Study Start

October 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations