Effects of a Combined Exercise Intervention on the Gut Microbiome of People With Type 2 Diabetes (GUTFIT)

April 28, 2026 updated by: Martin Senechal, University of New Brunswick

Understanding the GUT Microbiome Through a Fitness Intervention of Aerobic and Resistance Training for Individuals With Type 2 Diabetes Mellitus (GUTFIT Study)

The goal of this experimental trial is to learn about the changes in bacterial diversity in individuals with type 2 diabetes who perform endurance and strength training at different intensities.

Participants with type 2 diabetes will be randomly assigned to 16 weeks of either moderate-intensity endurance and strength training or high-intensity endurance and strength training.

Researchers will compare the moderate-intensity and high-intensity exercise groups for differences in glycemia and bacterial diversity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is unclear if performing aerobic training (AT) and resistance training (RT) at a higher intensity in people with type 2 diabetes mellitus (T2DM) would generate greater improvement in HbA1c and if this would be associated with increased gut microbiome diversity.

Therefore, the objective of this study is to test whether performing resistance training and aerobic exercise (RT+AT) at a high intensity for 16 weeks will significantly improve glycemic control (HbA1c) and if this change is associated with an increase in gut microbiome diversity compared to performing RT+AT at a moderate intensity in individuals with poor glycemic control. We hypothesize that individuals performing RT+AT at a high intensity will significantly reduce HbA1c and improve gut microbiome diversity compared to individuals performing RT+AT at a moderate intensity.

Methods: This study is a parallel-group, single-blinded, randomized trial including 40 adults (50% males and females) living with T2DM. Participants will be allocated to one of two treatment groups: 1) high intensity or 2) moderate intensity for 16 weeks.

A total of 40 participants (n = 20 for each sex) living with T2DM with poor glycemic control (HbA1c => 7.0%), aged between 19-64 years, who do not currently meet the recommended levels of physical activity for optimal health, (i.e., 150 min of moderate-to-vigorous physical activity + 2 days/week of resistance training) will be recruited.

Intervention: Participants will undergo a supervised exercise intervention of RT+AT for 16 weeks, performed at high or moderate intensity. 1) High intensity: AT will be performed at 70-80% heart rate reserve and 8-10 repetitions (75-80% maximal strength). 2) Moderate intensity: AT will be performed at 45-55% heart rate reserve and 12-15 repetitions (65-70% maximal strength). AT will consist of expending 10 kcal/kg per week, while RT will consist of 2 days of resistance training per week as per the recommendations. Our previous work shows that participants could perform this type of intensity; therefore, no problems are anticipated. Exercise intensity will be monitored using heart rate for aerobic training and the OMNI-RES scale (1-10) for resistance training.

Primary Outcomes: All HbA1c tests will be performed using a validated DCA Vantage® Analyzer (Siemens, Germany). Participants will undergo HbA1c tests at baseline and post-intervention (16 weeks). The gut microbiome composition will be determined at baseline and post-intervention in participant feces using next-generation sequencing (Illumina MiSeq) of 16S ribosomal RNA genes.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • 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
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B5A3
        • Cardiometabolic Exercise & Lifestyle Laboratory

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 19 - 64 years old;
  • Diagnosed with type 2 diabetes;
  • An HbA1c >= 7.0%;
  • Not currently meeting the recommended levels of physical activity for optimal health (i.e., 150 minutes of moderate-to-vigorous physical activity and 2+ days/week of resistance training);
  • Average less than 10,000 steps per day over the last seven days;
  • No change in diabetes medications over the last three months.

Exclusion Criteria:

  • Not diagnosed with type 2 diabetes;
  • Partaking in a self-reported regular exercise regimen, defined as consistent participation in running or jogging activity, attending exercise classes every week, or averaging 10,000 steps per day or more over seven days;
  • Currently performing two days of resistance training per week;
  • Having an injury that would prevent safe participation in the intervention;
  • A self-reported diagnosis of low iron concentrations, anemia, or being treated for these conditions;
  • A diagnosis of any red blood cell altering condition (i.e., sickle cell anemia, poikilocytosis);
  • Currently living with any cardiovascular disease which would impact the ability to participate in exercise safely;
  • Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track intensity.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High intensity
Participants will perform high-intensity aerobic and strength training exercises.
Other: High intensity
High intensity exercise
Active Comparator: Moderate Intensity
Participants will perform moderate-intensity aerobic and strength training exercises.
Other: Moderate intensity
Moderate intensity exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control through glycated hemoglobin
Time Frame: 16 weeks
Change in glycated hemoglobin (HbA1c)
16 weeks
Gut microbiome diversity through 16S ribosomal RNA genes
Time Frame: 16 weeks
Change in the composition of the gut microbiome based on sequencing of 16S ribosomal RNA genes
16 weeks

Collaborators and Investigators

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

Sponsor

University of New Brunswick

Collaborators

Laval University

Investigators

  • Principal Investigator: Martin Senechal, Ph.D., University of New Brunswick

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)

February 29, 2024

Primary Completion (Actual)

April 7, 2026

Study Completion (Actual)

April 7, 2026

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-114

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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