Changes in Intrahepatic Lipids With Exercise
Attenuation of Interhepatic Fat and Hepatic Biomarkers With Exercise
1 other identifier
interventional
57
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
June 30, 2014
CompletedFirst Posted
Study publicly available on registry
July 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJanuary 23, 2018
January 1, 2018
3.7 years
June 30, 2014
January 20, 2018
Conditions
Keywords
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
EXPERIMENTALHigh-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
Continuous moderate exercise group
EXPERIMENTALContinuous 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.
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
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.
Eligibility Criteria
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
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.
PMID: 28941598DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jill Kanaley, PhD
University of Missouri-Columbia
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