Clinical trial NCT02706093: Metabolic Adaptations in Response to High Intensity Interval Training in Obese Adults
Official title: Metabolic Adaptations in Response to High Intensity Interval Training in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Intolerance
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: Change from Baseline at 3 months
Secondary outcomes:
measure: Continuous Glucose Monitoring
timeFrame: Change from Baseline at 3 months
measure: Resting Metabolic Rate
timeFrame: baseline and 3 months
measure: Muscle Biopsy
timeFrame: Change from Baseline at 3 months
measure: Adipose Tissue Biopsy
timeFrame: Change from Baseline at 3 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Suzette Howton
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeff Horowitz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryan BJ, Schleh MW, Ahn C, Ludzki AC, Gillen JB, Varshney P, Van Pelt DW, Pitchford LM, Chenevert TL, Gioscia-Ryan RA, Howton SM, Rode T, Hummel SL, Burant CF, Little JP, Horowitz JF. Moderate-Intensity Exercise and High-Intensity Interval Training Affect Insulin Sensitivity Similarly in Obese Adults. J Clin Endocrinol Metab. 2020 Aug 1;105(8):e2941-59. doi: 10.1210/clinem/dgaa345.