Comparing the Effects of Different Types of Exercise on Glucose Handling

February 2, 2024 updated by: University of Waterloo

Comparing the Effects of Different Types of Exercise on Glucose Handling and Muscle Metabolism in Young Males and Females

The purpose of the proposed study is to compare the acute effects of different types of exercise modalities on glucose handling in young, healthy males and females. The exercise modalities that will be compared include: a high intensity interval exercise (HIIE) protocol, a moderate intensity continuous exercise (MICE) protocol and a low-load, high-repetition (LL-HR) resistance exercise protocol.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to compare the effects of different exercise modalities (High intensity interval exercise, Moderate intensity continuous exercise, and Low-load-high repetition resistance exercise) on blood sugar control in young healthy, males and females. To test this theory, a sugar challenge (oral glucose tolerance test - OGTT) will be performed during the pre-testing visit to determine the baseline blood sugar response. An OGTT will also be performed 2 hours after each single exercise session to determine how each type of exercise affects the blood sugar response. Investigators will take multiple blood samples throughout the trial to allow us to measure blood sugar, insulin and concentrations and oxidative stress. Muscle biopsies will be taken before and after each exercise bout so that investigators can examine the underlying mechanisms that contribute to the effectiveness of the different types of exercise on blood sugar control. Investigators will also use an ultrasound to measure factors related to of cardiovascular health such as artery stress and vascular conductance during the exercise bouts. Direct benefits of this study include characterizing sex differences of blood sugar handling after single exercise sessions. This study could have direct benefits on deterring the effectiveness of different forms of exercise on blood sugar levels.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • University of Waterloo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • In order to participate in this study, participants must be a healthy man or woman between the ages of 18 and 30 years.

Exclusion Criteria:

  • Presence of chronic health condition(s) [i.e. metabolic (i.e. Type 1 or type 2 diabetes), cardiovascular (i.e hypertension), respiratory (i.e. chronic pulmonary obstructive disorder) or digestive (i.e. ulcerative colitis) disorders.

    • Are pregnant, or suspect that they may be pregnant, or nursing
    • Inability to complete the single exercise sessions.
    • Regularly participate in cardiovascular (>3 sessions/week) or resistance training (>2 sessions/week) exercise.
    • Have an allergy to local anesthetic (or family history of allergy)
    • Have undergone a barium swallow or an infusion of a contrast agent in the past 3 weeks
    • Are taking prescription anti-coagulant or anti-platelet medications (e.g., warfarin, heparin, clopidogrel)
    • Inability to exercise as suggested by the get active questionnaire (GAQ)
    • BMI > 27 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control Oral Glucose Tolerance Test
This visit will include a baseline OGTT to be used as a pre-exercise baseline measure for each of the arms. Participants will then consume a 75g glucose beverage (Trutol, Thermo Scientific) and blood samples will be drawn at 0, 10, 20, 30, 45, 60, 75, 90 and 120 minutes post consumption.
Other: Control Oral Glucose Tolerance Test
control oral glucose tolerance test
Other: Mixed Exercise
exercise performed in randomized order
Experimental: High intensity interval exercise (HIIE)
Participants performed a High intensity interval exercise (HIIE) bout which includes 10 x 1 min at 90% maximum heart rate (HRmax) with 5 min warm up and 5 min cool down at 50watts (low state steady cycling). 90mins following the exercise bout participants will undergo another oral glucose tolerance test.
Other: Control Oral Glucose Tolerance Test
control oral glucose tolerance test
Other: Mixed Exercise
exercise performed in randomized order
Experimental: Moderate intensity continuous exercise (MICE)
Participants performed a Moderate intensity continuous exercise (MICE) bout which includes 30 min at 65% maximal aerobic capacity (VO2max). 90mins following the exercise bout participants will undergo another oral glucose tolerance test.
Other: Control Oral Glucose Tolerance Test
control oral glucose tolerance test
Other: Mixed Exercise
exercise performed in randomized order
Experimental: Low-load, high-repetition resistance exercise (LL-HR)
Participants performed a Low-load, high-rep resistance exercise (LL-HR) bout which includes a whole body resistance exercise bout, 3 sets at 30% maximum strength (1RM) for leg press, knee extension, hamstring curl, lat pulldown, shoulder press, chest press, 20-25 reps, last set to failure. 90mins following the exercise bout participants will undergo another oral glucose tolerance test.
Other: Control Oral Glucose Tolerance Test
control oral glucose tolerance test
Other: Mixed Exercise
exercise performed in randomized order

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Insulin sensitivity change
Time Frame: 120mins
Assess the changes in insulin sensitivity pre to post exercise
120mins
Blood insulin change
Time Frame: 120mins
To assess the effect of sex and exercise on basal and post-exercise blood insulin
120mins
Blood glucose change
Time Frame: 120mins
To assess the effect of sex and exercise on basal and post-exercise blood glucose.
120mins
Blood c-peptide change
Time Frame: 120mins
To assess the effect of sex and exercise on basal and post-exercise blood c-peptide.
120mins

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TBC1 domain family member 4 change (TBC1D4)
Time Frame: 35mins
examine protein content changes from pre to post exercise
35mins
TBC1 domain family member 1 change (TBC1D1)
Time Frame: 35mins
examine protein content changes from pre to post exercise
35mins
protein kinase B change
Time Frame: 35mins
examine protein content changes from pre to post exercise
35mins
5' adenosine monophosphate-activated protein kinase change
Time Frame: 35mins
examine protein content changes from pre to post exercise
35mins
glucose transporter 4 change (GLUT4)
Time Frame: 35mins
examine protein content changes from pre to post exercise
35mins
estrogen concentration
Time Frame: 30mins
to assess the differences in estrogen concentration between males and females
30mins
progesterone concentration
Time Frame: 30mins
to assess the differences in progesterone concentration between males and females
30mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Waterloo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ORE #22477

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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