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OpenTrials
Completed

NCT Number: NCT02706093

Metabolic Adaptations in Response to High Intensity Interval Training in Obese Adults

The overall objectives are to:

1. Assess mechanisms underlying HIIT-induced improvements in insulin resistance at the whole-body, tissue, and cellular levels. 2. Systematically compare different HIIT regimens to help identify effective "doses" of HIIT that may be optimal for improving metabolic health in obese adults. 3. Assess the ability/willingness of obese subjects to adhere to a long-term HIIT program.

Findings from these studies will greatly expand knowledge about the effects of HIIT on metabolic health, and will provide valuable information for development of programs aimed at maximizing key metabolic benefits of exercise.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suzette Howton

Ann Arbor, Michigan, 48178, United States

About this study

If subjects are eligible for the study, they will be randomized into one of four different exercise training groups. Before training (and twice after 3 months of training) subjects will participate in a "clinical study" in which they will be required to stay overnight in the hospital. During the clinical study, the research team will perform a series of metabolic tests. Before and after the 3 months of training, the research team will assess subjects "free-living" 24h blood sugar control using a Continuous Glucose Monitor (CGM). The research team will measure several other relevant clinical markers (e.g., whole body and regional body fat assessments [Dual Energy X-ray Absorptiometry (DEXA) and Magnetic Resonance Imager (MRI)], hepatic lipid accumulation [MRI analysis], blood lipid profile, resting metabolic rate, glycated hemoglobin [hemoglobin A1c]). After the first 3 months of training, adherence to the subjects assigned training program will be tracked for the next 9 months (1 year of training in total). One year after initiating a training program, subjects will be asked to return to the clinic for a quick follow-up visit where the research team will complete some standard clinical assessments (e.g., body weight, body composition, blood pressure, and a blood sample).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18-40
  • Body Mass Index: 30-40 kg/m2
  • Waist circumference: 88-98cm for women and 100-110cm for men
  • Glucose intolerant (i.e., 2h glucose concentration during a screening oral glucose tolerance test (OGTT)= 140-199mg/dl
  • No regularly planned exercise/physical activity
  • Women must have regularly occurring menses and must be premenopausal

Exclusion criteria

  • EKG abnormalities as assessed by the cardiologist on the research team
  • Evidence/history of cardiovascular or metabolic disease
  • Medications known to affect lipid or glucose metabolism
  • Pregnant or lactating
  • Tobacco or e-cigarette use

Treatment and study plan

High Intensity Interval Training #1

Other

(HIIT#1) 10 x 1 min. at ~90%HRmax - with low intensity warm-up, recovery, and cool down - total of 25 min/session .

Moderate Intensity Continuous Training

Other

Moderate-intensity continuous training (MICT) = steady-state exercise at 60-70%HRmax for 45min. Representing a commonly prescribed exercise program.

High Intensity Interval Training #2

Other

(HIIT #2) 5 x 1 min at 90%HRmax + 10 min steady-state exercise at 70%HRmax [25min; ~150kcals; 4d/wk]

High Intensity Interval Training #3

Other

(HIIT #3) 5 x 1 min at 90%HRmax [15min; ~90kcals; 4d/wk]

Primary outcomes

  1. Insulin Sensitivity

    Time frame: Change from Baseline at 3 months

    A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity

Secondary outcomes

  1. Continuous Glucose Monitoring

    Time frame: Change from Baseline at 3 months

  2. Resting Metabolic Rate

    Time frame: baseline and 3 months

  3. Muscle Biopsy

    Time frame: Change from Baseline at 3 months

    To measure Mitochondrial Proteins

  4. Adipose Tissue Biopsy

    Time frame: Change from Baseline at 3 months

    To measure cytokines

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: HT

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2016
Registry last updated
Aug 25, 2022

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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