Back to resultsDoes Biological Sex Influence Insulin Sensitivity and Muscle Metabolism Following High-intensity Interval Exercise?
Primary Purpose
Exercise
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Seated Rest (Non-exercise control)
High-intensity interval exercise
Sponsored by
About this trial
This is an interventional basic science trial for Exercise
Eligibility Criteria
Inclusion Criteria: 18-35 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 1-3 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 Exclusion Criteria: 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Females
Males
Arm Description
Female participant group
Male participant group
Outcomes
Primary Outcome Measures
Insulin area under the curve
Insulin area under the curve measured during glucose tolerance test
Secondary Outcome Measures
Glucose area under the curve
Glucose area under the curve measured during glucose tolerance test
Mean insulin concentration
Mean insulin concentration measured during glucose tolerance test
Mean glucose concentration
Mean glucose concentration measured during glucose tolerance test
Peak insulin concentration
Peak insulin concentration measured during the glucose tolerance test
Peak glucose concentration
Peak insulin concentration measured during the glucose tolerance test
Insulin:glucose ratio
Insulin to glucose ration measured during the glucose tolerance test
Postprandial glucose oxidation
Postprandial glucose oxidation measured with a metabolic tracer
Skeletal muscle glycogen content
Muscle glycogen use during exercise
Skeletal muscle contractile signaling protein content
Measured via western blotting
Skeletal muscle insulin signaling
Measured via western blotting
Mitochondrial gene expression
Measured via Reverse transcription polymerase chain reaction
Muscle protein synthesis rates
Muscle protein synthesis rates assessed by incorporation of oral stable isotope tracer following exercise
Local muscle oxygenation
Muscle oxygenation (vastus lateralis) assessed with near-infrared spectroscopy (NIRS)
Local muscle oxygenation
Muscle oxygenation (vastus lateralis) assessed with NIRS during and following thigh cuff inflation
Full Information
NCT ID
NCT06074003
First Posted
September 27, 2023
Last Updated
October 4, 2023
Sponsor
University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT06074003
Brief Title
Does Biological Sex Influence Insulin Sensitivity and Muscle Metabolism Following High-intensity Interval Exercise?
Official Title
Does Biological Sex Influence Insulin Sensitivity and Muscle Metabolism Following High-intensity Interval Exercise?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
The primary purpose of this study is to determine if biological sex influences the effects of high-intensity interval exercise (HIIE) on insulin sensitivity and muscle mechanisms. The investigators will measure insulin sensitivity and muscle outcomes of participants on two separate occasions: 1) Following 30 minutes of sitting in the lab; and 2) Following a single session of HIIE on a stationary bike. Insulin sensitivity will be measured by taking blood samples after participants consume a sugary drink. Muscle outcomes will be measured by taking a small amount of muscle from the vastus lateralis (thigh) muscle. Groups of male and female participants will be recruited and tested using best practice guidelines for sex-based comparisons of exercise responses.
The study will advance knowledge regarding the potential for biological sex to influence the metabolic responses high-intensity exercise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Females
Arm Type
Experimental
Arm Description
Female participant group
Arm Title
Males
Arm Type
Experimental
Arm Description
Male participant group
Intervention Type
Other
Intervention Name(s)
Seated Rest (Non-exercise control)
Intervention Description
Sitting for 30 minutes
Intervention Type
Other
Intervention Name(s)
High-intensity interval exercise
Intervention Description
Performing a single session of high-intensity interval exercise on a cycle ergometer
Primary Outcome Measure Information:
Title
Insulin area under the curve
Description
Insulin area under the curve measured during glucose tolerance test
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Glucose area under the curve
Description
Glucose area under the curve measured during glucose tolerance test
Time Frame
3 hours
Title
Mean insulin concentration
Description
Mean insulin concentration measured during glucose tolerance test
Time Frame
3 hours
Title
Mean glucose concentration
Description
Mean glucose concentration measured during glucose tolerance test
Time Frame
3 hours
Title
Peak insulin concentration
Description
Peak insulin concentration measured during the glucose tolerance test
Time Frame
3 hours
Title
Peak glucose concentration
Description
Peak insulin concentration measured during the glucose tolerance test
Time Frame
3 hours
Title
Insulin:glucose ratio
Description
Insulin to glucose ration measured during the glucose tolerance test
Time Frame
3 hours
Title
Postprandial glucose oxidation
Description
Postprandial glucose oxidation measured with a metabolic tracer
Time Frame
3 hours
Title
Skeletal muscle glycogen content
Description
Muscle glycogen use during exercise
Time Frame
immediately before and after exercise
Title
Skeletal muscle contractile signaling protein content
Description
Measured via western blotting
Time Frame
immediately before and after exercise
Title
Skeletal muscle insulin signaling
Description
Measured via western blotting
Time Frame
1hr into glucose tolerance test
Title
Mitochondrial gene expression
Description
Measured via Reverse transcription polymerase chain reaction
Time Frame
Change from pre-exercise to 3hr post-exercise
Title
Muscle protein synthesis rates
Description
Muscle protein synthesis rates assessed by incorporation of oral stable isotope tracer following exercise
Time Frame
3hr post-exercise
Title
Local muscle oxygenation
Description
Muscle oxygenation (vastus lateralis) assessed with near-infrared spectroscopy (NIRS)
Time Frame
During exercise
Title
Local muscle oxygenation
Description
Muscle oxygenation (vastus lateralis) assessed with NIRS during and following thigh cuff inflation
Time Frame
Pre-exercise, immediately post-exercise and 2 hrs post-exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-35 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
1-3 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
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenna Gillen, PhD
Phone
14169783244
Email
jenna.gillen@utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Esfafanos, MSc
Organizational Affiliation
University of Toronto
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Biological Sex Influence Insulin Sensitivity and Muscle Metabolism Following High-intensity Interval Exercise?
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