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

Primary Purpose

Glucose Intolerance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Interval Training #1
Moderate intensity continuous training
High Intensity Interval Training #2
High Intensity Interval Training #3
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Glucose Intolerance

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Suzette Howton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

High Intensity Interval Training #1

Moderate intensity continuous training

High Intensity Interval Training #2

High Intensity Interval Training #3

Arm Description

Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.

Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.

Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.

Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Continuous Glucose Monitoring
Resting Metabolic Rate
Muscle Biopsy
To measure Mitochondrial Proteins
Adipose Tissue Biopsy
To measure cytokines

Full Information

First Posted
March 2, 2016
Last Updated
August 22, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02706093
Brief Title
Metabolic Adaptations in Response to High Intensity Interval Training in Obese Adults
Acronym
HT
Official Title
Metabolic Adaptations in Response to High Intensity Interval Training in Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 3, 2016 (Actual)
Primary Completion Date
May 4, 2022 (Actual)
Study Completion Date
May 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval Training #1
Arm Type
Other
Arm Description
Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.
Arm Title
Moderate intensity continuous training
Arm Type
Other
Arm Description
Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.
Arm Title
High Intensity Interval Training #2
Arm Type
Other
Arm Description
Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.
Arm Title
High Intensity Interval Training #3
Arm Type
Other
Arm Description
Obese adults with impaired glucose tolerance will be randomized into one of four different exercise training groups for a 3 month exercise intervention.
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Training #1
Intervention Description
(HIIT#1) 10 x 1 min. at ~90%HRmax - with low intensity warm-up, recovery, and cool down - total of 25 min/session .
Intervention Type
Other
Intervention Name(s)
Moderate intensity continuous training
Intervention Description
Moderate-intensity continuous training (MICT) = steady-state exercise at 60-70%HRmax for 45min. Representing a commonly prescribed exercise program.
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Training #2
Intervention Description
(HIIT #2) 5 x 1 min at 90%HRmax + 10 min steady-state exercise at 70%HRmax [25min; ~150kcals; 4d/wk]
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Training #3
Intervention Description
(HIIT #3) 5 x 1 min at 90%HRmax [15min; ~90kcals; 4d/wk]
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity
Time Frame
Change from Baseline at 3 months
Secondary Outcome Measure Information:
Title
Continuous Glucose Monitoring
Time Frame
Change from Baseline at 3 months
Title
Resting Metabolic Rate
Time Frame
baseline and 3 months
Title
Muscle Biopsy
Description
To measure Mitochondrial Proteins
Time Frame
Change from Baseline at 3 months
Title
Adipose Tissue Biopsy
Description
To measure cytokines
Time Frame
Change from Baseline at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Horowitz
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suzette Howton
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48178
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32492705
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.
Results Reference
derived

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

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