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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
Sponsor:
Information provided by (Responsible Party):
Jeffrey F Horowitz, University of Michigan

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.


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 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

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]




Primary Outcome Measures :
  1. 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 :
  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



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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

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

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