Type 2 DiabetesGUTFITNCT06268743
Effects of a Combined Exercise Intervention on the Gut Microbiome of People With Type 2 Diabetes
A study testing High intensity and Moderate intensity in people with Type 2 Diabetes, run by University of New Brunswick at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- High intensity and Moderate intensity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 29 Feb 2024to 7 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cardiometabolic Exercise & Lifestyle Laboratory
Fredericton, New Brunswick, E3B5A3
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- High intensity, Moderate intensity
- Keywords
- Exercise intensity, Aerobic training, Resistance training, Gut microbiome, Physical activity, Glycemia, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensityOther
High intensity exercise
Moderate intensityOther
Moderate intensity exercise
| Study group | Role | What they receive |
|---|---|---|
| High intensity | Experimental | Participants will perform high-intensity aerobic and strength training exercises. Receives: Other: High intensity |
| Moderate Intensity | Active comparator | Participants will perform moderate-intensity aerobic and strength training exercises. Receives: Other: Moderate intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control through glycated hemoglobin
Change in glycated hemoglobin (HbA1c)
Measured: 16 weeks
Gut microbiome diversity through 16S ribosomal RNA genes
Change in the composition of the gut microbiome based on sequencing of 16S ribosomal RNA genes
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start29 Feb 2024
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group, single blinded, randomized trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Brunswick
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University
- Responsible party
- Principal investigator, Martin Senechal, University of New Brunswick
- Investigators
- Martin Senechal, Ph.D., Principal investigator, University of New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268743
- Sponsor's protocol ID
- 2023-114
- Acronym
- GUTFIT
- Status last verified
- Apr 2026
- First submitted
- 12 Feb 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thomson AM, Drost DC, Johannsen NM, Silvestri C, Senechal M. Understanding the gut microbiome through a fitness intervention of aerobic and resistance training for individuals with type 2 diabetes mellitus (GUTFIT: A Study Protocol). PLoS One. 2026 Feb 23;21(2):e0343294. doi: 10.1371/journal.pone.0343294. eCollection 2026.
PubMed 41729946
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the GUT Microbiome Through a Fitness Intervention of Aerobic and Resistance Training for Individuals With Type 2 Diabetes Mellitus (GUTFIT Study)
- ClinicalTrials.gov ID
- NCT06268743
- Acronym / sponsor ID
- GUTFIT / 2023-114
- Conditions
- Type 2 Diabetes
- Keywords
- Exercise intensity, Aerobic training, Resistance training, Gut microbiome, Physical activity, Glycemia, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of New BrunswickUniversity, hospital or other
- Collaborators
- Laval University
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel group, single blinded, randomized trial
| Arm | Type | Receives |
|---|---|---|
| High intensity | Experimental | Other: High intensityParticipants will perform high-intensity aerobic and strength training exercises. |
| Moderate Intensity | Active comparator | Other: Moderate intensityParticipants will perform moderate-intensity aerobic and strength training exercises. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensityHigh intensity exercise | Other | High intensity |
| Moderate intensityModerate intensity exercise | Other | Moderate Intensity |
Primary outcome
Glycemic control through glycated hemoglobin
Time frame: 16 weeks
Change in glycated hemoglobin (HbA1c)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 41729946Thomson AM, Drost DC, Johannsen NM, Silvestri C, Senechal M. Understanding the gut microbiome through a fitness intervention of aerobic and resistance training for individuals with type 2 diabetes mellitus (GUTFIT: A Study Protocol). PLoS One. 2026 Feb 23;21(2):e0343294. doi: 10.1371/journal.pone.0343294. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Senechal, Ph.D. principal investigator
University of New Brunswick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity and Moderate intensity in people with Type 2 Diabetes, run by University of New Brunswick at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control through glycated hemoglobin (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06268743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.