Glucose IntoleranceHTNCT02706093
Metabolic Adaptations in Response to High Intensity Interval Training in Obese Adults
A study testing High Intensity Interval Training (HIIT) and Moderate-intensity continuous training (MICT) in people with Glucose Intolerance, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Glucose Intolerance
- What is being tested?
- High Intensity Interval Training (HIIT) and Moderate-intensity continuous training (MICT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2016to 4 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-40
- Body Mass Index: 30-40 kg/m2
- Waist circumference: 88-98cm for women and 100-110cm for men
- No regularly planned exercise/physical activity
- Women must have regularly occurring menses and must be premenopausal
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
If subjects are eligible for the study, they will be randomized into one of two 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).
- Conditions
- Glucose Intolerance
- Being tested
- High Intensity Interval Training (HIIT), Moderate-intensity continuous training (MICT)
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Training (HIIT)Other
(HIIT) 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 (MICT)Other
Moderate-intensity continuous training (MICT) = steady-state exercise at 60-70%HRmax for 45min. Representing a commonly prescribed exercise program.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training (HIIT) | Other | Obese adults with impaired glucose tolerance will be randomized into one of two different exercise training groups for a 3 month exercise intervention. Receives: Other: High Intensity Interval Training (HIIT) |
| Moderate intensity continuous training (MICT) | Other | Obese adults with impaired glucose tolerance will be randomized into one of two different exercise training groups for a 3 month exercise intervention. Receives: Other: Moderate-intensity continuous training (MICT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
A hyperinsulinemic-euglycemic clamp was used to assess peripheral insulin sensitivity. Briefly, a primed, continuous infusion of insulin (40 mU/m^2/min) was administered; blood glucose was assessed every 5 minutes and 20% dextrose (D20 enriched with [6-6 d2]glucose) was infused at a variable rate to accommodate changes in blood glucose in order to maintain blood glucose at the participants' overnight fasted levels. About 2 hours after beginning the insulin infusion, when blood glucose concentration stabilized without further changes in the rate of D20 infusion for ≥ ~20 minutes, arterialized blood samples were collected every 5 minutes during the final 20 minutes of the clamp for the determination of steady state tracer-labeled glucose enrichment in plasma to calculate the rate of glucose disposal.
Measured: Change from Baseline after 3 months of exercise training
Secondary outcomes (4)
VO2peak
Change in aerobic capacity between baseline and after 3 months of training
Measured: Change from Baseline after 3 months of exercise training
Resting Metabolic Rate
energy expenditure while at rest
Measured: Change from Baseline after 3 months of exercise training
Hepatic Fat %
Change in abundance of fat in the liver - reported as % area (measured by MRI)
Measured: Change from Baseline after 3 months of exercise training
Visceral Fat Area (cm^2)
Change in fat accumulation in the visceral region - measured by MRI
Measured: Change from Baseline after 3 months of exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study start3 May 2016
- Primary completion4 May 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey F Horowitz, University of Michigan
- Investigators
- Jeff Horowitz, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706093
- Sponsor's protocol ID
- HUM00106883
- Acronym
- HT
- Status last verified
- Jul 2026
- First submitted
- 2 Mar 2016
- Last updated
- 24 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32492705
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Adaptations in Response to High Intensity Interval Training in Obese Adults
- ClinicalTrials.gov ID
- NCT02706093
- Acronym / sponsor ID
- HT / HUM00106883
- Conditions
- Glucose Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 3 May 2016 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Posted 24 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 two 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training (HIIT) | Other | Other: High Intensity Interval Training (HIIT)Obese adults with impaired glucose tolerance will be randomized into one of two different exercise training groups for a 3 month exercise intervention. |
| Moderate intensity continuous training (MICT) | Other | Other: Moderate-intensity continuous training (MICT)Obese adults with impaired glucose tolerance will be randomized into one of two different exercise training groups for a 3 month exercise intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18-40
- Body Mass Index: 30-40 kg/m2
- Waist circumference: 88-98cm for women and 100-110cm for men
- No regularly planned exercise/physical activity
- Women must have regularly occurring menses and must be premenopausal
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval Training (HIIT)(HIIT) 10 x 1 min. at ~90%HRmax - with low intensity warm-up, recovery, and cool down - total of 25 min/session . | Other | High Intensity Interval Training (HIIT) |
| Moderate-intensity continuous training (MICT)Moderate-intensity continuous training (MICT) = steady-state exercise at 60-70%HRmax for 45min. Representing a commonly prescribed exercise program. | Other | Moderate intensity continuous training (MICT) |
Primary outcome
Insulin Sensitivity
Time frame: Change from Baseline after 3 months of exercise training
A hyperinsulinemic-euglycemic clamp was used to assess peripheral insulin sensitivity. Briefly, a primed, continuous infusion of insulin (40 mU/m^2/min) was administered; blood glucose was assessed every 5 minutes and 20% dextrose (D20 enriched with [6-6 d2]glucose) was infused at a variable rate to accommodate changes in blood glucose in order to maintain blood glucose at the participants' overnight fasted levels. About 2 hours after beginning the insulin infusion, when blood glucose concentration stabilized without further changes in the rate of D20 infusion for ≥ ~20 minutes, arterialized blood samples were collected every 5 minutes during the final 20 minutes of the clamp for the determination of steady state tracer-labeled glucose enrichment in plasma to calculate the rate of glucose disposal.
4 secondary outcomes
VO2peak
Time frame: Change from Baseline after 3 months of exercise training
Resting Metabolic Rate
Time frame: Change from Baseline after 3 months of exercise training
Hepatic Fat %
Time frame: Change from Baseline after 3 months of exercise training
Visceral Fat Area (cm^2)
Time frame: Change from Baseline after 3 months of exercise training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32492705Ryan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Horowitz principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training (HIIT) and Moderate-intensity continuous training (MICT) in people with Glucose Intolerance, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: Change from Baseline after 3 months of exercise training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02706093, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.