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Completed

NCT Number: NCT02181270

Changes in Intrahepatic Lipids With Exercise

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.

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Key information

Conditions

Obese Body Weight Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Exercise

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

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.

Primary outcomes

  1. percent of intrahepatic fat as measured by magnetic resonance spectroscopy

    Time frame: 6 weeks

Secondary outcomes

  1. plasma cytokeratin 18 (ck18) units: (U/I)

    Time frame: 6 weeks

Other outcomes

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

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Attenuation of Interhepatic Fat and Hepatic Biomarkers With Exercise

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 3, 2014
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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