Overview

This trial is active, not recruiting.

Condition glucose intolerance
Treatments high intensity interval training #1, moderate intensity continuous training, high intensity interval training #2, high intensity interval training #3
Sponsor University of Michigan
Start date March 2016
End date January 2020
Trial size 120 participants
Trial identifier NCT02706093, HUM00106883

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Other)
Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.
high intensity interval training #1
(HIIT#1) 10 x 1 min. at ~90%HRmax - with low intensity warm-up, recovery, and cool down - total of 25 min/session .
(Other)
Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.
moderate intensity continuous training
Moderate-intensity continuos training (MICT) = steady-state exercise at 60-70%HRmax for 45min. Representing a commonly prescribed exercise program.
(Other)
Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.
high intensity interval training #2
(HIIT #2) 5 x 1 min at 90%HRmax + 10 min steady-state exercise at 70%HRmax [25min; ~150kcals; 4d/wk]
(Other)
Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.
high intensity interval training #3
(HIIT #3) 5 x 1 min at 90%HRmax [15min; ~90kcals; 4d/wk]

Primary Outcomes

Measure
Insulin Sensitivity
time frame: Change from Baseline at 3 months

Secondary Outcomes

Measure
Continuous Glucose Monitoring
time frame: Change from Baseline at 3 months
Resting Metabolic Rate
time frame: baseline and 3 months
Muscle Biopsy
time frame: Change from Baseline at 3 months
Adipose Tissue Biopsy
time frame: Change from Baseline at 3 months

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

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 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

Additional Information

Official title Metabolic Adaptations in Response to High Intensity Interval Training in Obese Adults
Principal investigator Jeff Horowitz
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Michigan.