Metabolic Adaptations in Response to High Intensity Interval Training in Obese Adults (HT)

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ClinicalTrials.gov Identifier: NCT02706093

Recruitment Status : Recruiting

First Posted : March 11, 2016

Last Update Posted : November 17, 2017

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Jeffrey F Horowitz, University of Michigan

Study Description

Brief Summary:

The overall objectives are to:

Assess mechanisms underlying HIIT-induced improvements in insulin resistance at the whole-body, tissue, and cellular levels.
Systematically compare different HIIT regimens to help identify effective "doses" of HIIT that may be optimal for improving metabolic health in obese adults.
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.

Condition or disease	Intervention/treatment	Phase
Glucose Intolerance	Other: High Intensity Interval Training #1 Other: Moderate intensity continuous training Other: High Intensity Interval Training #2 Other: High Intensity Interval Training #3	Not Applicable

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).

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Metabolic Adaptations in Response to High Intensity Interval Training in Obese Adults
Study Start Date :	March 2016
Estimated Primary Completion Date :	January 2020
Estimated Study Completion Date :	January 2025

Arms and Interventions

Arm	Intervention/treatment
High Intensity Interval Training #1 Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.	Other: 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 .
Moderate intensity continuous training Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.	Other: Moderate intensity continuous training 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 Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.	Other: 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]
High Intensity Interval Training #3 Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.	Other: High Intensity Interval Training #3 (HIIT #3) 5 x 1 min at 90%HRmax [15min; ~90kcals; 4d/wk]

Outcome Measures

Primary Outcome Measures :

Insulin Sensitivity [ Time Frame: Change from Baseline at 3 months ]
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity

Secondary Outcome Measures :

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 ]
To measure Mitochondrial Proteins
Adipose Tissue Biopsy [ Time Frame: Change from Baseline at 3 months ]
To measure cytokines

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706093

Contacts


Contact: Suzette Howton	734-647-9850	suzetter@med.umich.edu

Locations


United States, Michigan
Suzette Howton	Recruiting
Ann Arbor, Michigan, United States, 48178
Contact: Suzette Howton 734-647-9850 suzetter@med.umich.edu
Principal Investigator: jeff Horowitz

Sponsors and Collaborators

University of Michigan

Investigators


Principal Investigator:	Jeff Horowitz	University of Michigan

More Information


Responsible Party:	Jeffrey F Horowitz, Professor, Movement Science and Director, Substrate Metabolism Laboratory, University of Michigan
ClinicalTrials.gov Identifier:	NCT02706093 History of Changes
Other Study ID Numbers:	HUM00106883
First Posted:	March 11, 2016 Key Record Dates
Last Update Posted:	November 17, 2017
Last Verified:	November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:


Glucose Intolerance Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases

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