Does Biological Sex Influence Insulin Sensitivity and Muscle Metabolism Following High-intensity Interval Exercise?

Exercise Clinical Trial

Official title:

Does Biological Sex Influence Insulin Sensitivity and Muscle Metabolism Following High-intensity Interval Exercise?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074003
• Other study ID #: 44435
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: University of Toronto
• Contact: Jenna Gillen, PhD
• Phone: 14169783244
• Email: jenna.gillen[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Exercise
• Insulin Resistance

Intervention

Other:
• Seated Rest (Non-exercise control)
Sitting for 30 minutes
• High-intensity interval exercise
Performing a single session of high-intensity interval exercise on a cycle ergometer

Locations

Country	Name	City	State
Canada	Goldring Centre for High Performance Sport	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin area under the curve	Insulin area under the curve measured during glucose tolerance test	3 hours
Secondary	Glucose area under the curve	Glucose area under the curve measured during glucose tolerance test	3 hours
Secondary	Mean insulin concentration	Mean insulin concentration measured during glucose tolerance test	3 hours
Secondary	Mean glucose concentration	Mean glucose concentration measured during glucose tolerance test	3 hours
Secondary	Peak insulin concentration	Peak insulin concentration measured during the glucose tolerance test	3 hours
Secondary	Peak glucose concentration	Peak insulin concentration measured during the glucose tolerance test	3 hours
Secondary	Insulin:glucose ratio	Insulin to glucose ration measured during the glucose tolerance test	3 hours
Secondary	Postprandial glucose oxidation	Postprandial glucose oxidation measured with a metabolic tracer	3 hours
Secondary	Skeletal muscle glycogen content	Muscle glycogen use during exercise	immediately before and after exercise
Secondary	Skeletal muscle contractile signaling protein content	Measured via western blotting	immediately before and after exercise
Secondary	Skeletal muscle insulin signaling	Measured via western blotting	1hr into glucose tolerance test
Secondary	Mitochondrial gene expression	Measured via Reverse transcription polymerase chain reaction	Change from pre-exercise to 3hr post-exercise
Secondary	Muscle protein synthesis rates	Muscle protein synthesis rates assessed by incorporation of oral stable isotope tracer following exercise	3hr post-exercise
Secondary	Local muscle oxygenation	Muscle oxygenation (vastus lateralis) assessed with near-infrared spectroscopy (NIRS)	During exercise
Secondary	Local muscle oxygenation	Muscle oxygenation (vastus lateralis) assessed with NIRS during and following thigh cuff inflation	Pre-exercise, immediately post-exercise and 2 hrs post-exercise