Changes in Intrahepatic Lipids With Exercise

NCT ID: NCT02181270

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-06-01

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.

Detailed Description

Subjects will complete a liver spectroscopy scan to ensure that they have 5% body fat. Subjects passing screening will then have body composition measurement and aerobic capacity (VO2 peak) measured. Blood samples will also be taken and subjects will complete an oral glucose tolerance test. Upon completion of this testing subjects will be randomized into one of two groups: Continuous moderate exercise group or High-intensity interval exercise .

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. A 5 minute cool-down (50% VO2peak).

High-intensity interval exercise (HIIE): Subjects will perform 5-10 minute warm-up (50% VO2peak). Following the warm-up, the speed and incline of the treadmill will be increased so that subjects reach an exercise intensity that corresponds to 90% Heart Rate max. Subjects will exercise at this intensity for 4 minutes, after which the treadmill speed and incline will be reduced to an intensity between 55% and 70% Heart Rate max for 3 minutes. This procedure will be replicated three additional times for a total of four intervals/recovery periods. The total exercise commitment will be ~45 minutes.

After 4 wk of exercise training all subjects will undergo all of the initial testing.

Conditions

Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

high intensity exercise

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

Group Type: EXPERIMENTAL

high intensity exercise

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

continuous moderate exercise

Intervention Type: OTHER

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

high intensity exercise

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

Intervention Type: OTHER

continuous moderate 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jill Kanaley

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jill Kanaley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri

Columbia, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28941598 (View on PubMed)

Other Identifiers

IHEEX

Identifier Type: -

Identifier Source: org_study_id