NCT02706093

Brief Summary

The overall objectives are to:

  1. 1.Assess mechanisms underlying HIIT-induced improvements in insulin resistance at the whole-body, tissue, and cellular levels.
  2. 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. 3.Assess the ability/willingness of obese subjects to adhere to a long-term HIIT program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 3, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

6 years

First QC Date

March 2, 2016

Last Update Submit

August 22, 2022

Conditions

Glucose Intolerance

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity

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

    Change from Baseline at 3 months

Secondary Outcomes (4)

  • Continuous Glucose Monitoring

    Change from Baseline at 3 months

  • Resting Metabolic Rate

    baseline and 3 months

  • Muscle Biopsy

    Change from Baseline at 3 months

  • Adipose Tissue Biopsy

    Change from Baseline at 3 months

Study Arms (4)

High Intensity Interval Training #1

OTHER

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

Moderate intensity continuous training

OTHER

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

High Intensity Interval Training #2

OTHER

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

High Intensity Interval Training #3

OTHER

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

Interventions

High Intensity Interval Training #1OTHER

(HIIT#1) 10 x 1 min. at \~90%HRmax - with low intensity warm-up, recovery, and cool down - total of 25 min/session .

High Intensity Interval Training #1
Moderate intensity continuous trainingOTHER

Moderate-intensity continuous training (MICT) = steady-state exercise at 60-70%HRmax for 45min. Representing a commonly prescribed exercise program.

Moderate intensity continuous training
High Intensity Interval Training #2OTHER

(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 #2
High Intensity Interval Training #3OTHER

(HIIT #3) 5 x 1 min at 90%HRmax \[15min; \~90kcals; 4d/wk\]

High Intensity Interval Training #3

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suzette Howton

Ann Arbor, Michigan, 48178, United States

Location

Related Publications (1)

  • 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.

    PMID: 32492705DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jeff Horowitz

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Movement Science and Director, Substrate Metabolism Laboratory

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 11, 2016

Study Start

May 3, 2016

Primary Completion

May 4, 2022

Study Completion

May 4, 2022

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)