NCT06074003

Brief Summary

High-intensity interval exercise (HIIE) is a type of exercise that involves alternating periods of intense exercise with periods of rest. HIIE has been shown to improve many aspects of cardiovascular and metabolic health in a time-efficient manner (e.g., only 20 minutes per exercise session). An important health benefit of exercise is improved blood sugar control, which can help reduce the risk of metabolic diseases like type 2 diabetes. A single session of HIIE has been shown to improve blood sugar in males, but it is unknown if females achieve the same health benefit. It is also not fully understood how exercise improves blood sugar in males and females. Therefore, the purpose of this project is 1) to determine if a single session of HIIE improves blood sugar control in males and females, and 2) to evaluate if changes in skeletal muscle can explain the beneficial effects of HIIE on blood sugar.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

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

September 27, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2025

Completed
Last Updated

August 19, 2025

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

September 27, 2023

Last Update Submit

August 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Insulin area under the curve

    Insulin area under the curve measured during glucose tolerance test

    3 hours

Secondary Outcomes (14)

  • Glucose area under the curve

    3 hours

  • Mean insulin concentration

    3 hours

  • Mean glucose concentration

    3 hours

  • Peak insulin concentration

    3 hours

  • Peak glucose concentration

    3 hours

  • +9 more secondary outcomes

Study Arms (2)

Females

EXPERIMENTAL

Female participant group

Other: Seated Rest (Non-exercise control)Other: High-intensity interval exercise

Males

EXPERIMENTAL

Male participant group

Other: Seated Rest (Non-exercise control)Other: High-intensity interval exercise

Interventions

Sitting for 30 minutes

FemalesMales

Performing a single session of high-intensity interval exercise on a cycle ergometer

FemalesMales

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • yrs
  • VO2peak considered recreationally active as defined as 'fair' or 'good' (males: 41.6- 50.5ml/kg/min; females: 35-41.9 ml/kg/min) based on Canadian Society for Exercise Physiology (CSEP) normative fitness values.
  • BMI between 18-27 kg/m2
  • structured exercise sessions/week, and not training for any specific sport
  • Weight stable (within ± 2kg for at least 6 months)
  • Eumenorrheic (female only), defined as menstrual cycle lengths ≥ 21 days and ≤ 35 days resulting in 9 or more consecutive periods per year)
  • Non-smoker

You may not qualify if:

  • Diagnosed with cardiovascular or metabolic disease, hyper- or hypogonadism, and/or polycystic ovarian syndrome (PCOS)
  • The use of medication for managing blood glucose or lipid metabolism
  • Current use of oral contraceptives or use within the last 3 months
  • Irregular menstrual cycles (\<21 days or \>35 days)
  • Pregnant, lactating, or menopausal
  • Recreational smoking of any kind
  • Inability to perform the study exercise protocols or follow the pre-trial dietary or physical activity controls
  • Taking medications affecting substrate metabolism (corticosteroids or nSAIDs)
  • Actively engaging in a low-carbohydrate diet (e.g., ketogenic, Atkins)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre for High Performance Sport

Toronto, Ontario, M5S2C9, Canada

Location

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stephanie Estafanos, MSc

    University of Toronto

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 10, 2023

Study Start

October 15, 2023

Primary Completion

June 26, 2025

Study Completion

June 26, 2025

Last Updated

August 19, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations