Impact of different exercise intensities on gut health in people with type 2 diabetes
Understanding the GUT Microbiome Through a Fitness Intervention of Aerobic and Resistance Training for Individuals With Type 2 Diabetes Mellitus (GUTFIT Study)
This study is testing whether high-intensity exercise can improve blood sugar levels and gut health more than moderate-intensity exercise in people with type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 19 Years to 64 Years |
| Sex | All |
| Sponsor | University of New Brunswick Academic / other |
| Locations | 1 site (Fredericton, New Brunswick) |
| Trial ID | NCT06268743 on ClinicalTrials.gov |
What this trial studies
This trial investigates how varying intensities of aerobic and resistance training affect glycemic control and gut microbiome diversity in individuals with type 2 diabetes. Participants will be randomly assigned to either a high-intensity or moderate-intensity exercise program for 16 weeks. The study aims to determine if higher intensity training leads to greater improvements in HbA1c levels and bacterial diversity compared to moderate intensity. A total of 40 adults with poor glycemic control will be included in this parallel-group, single-blinded trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19-64 with type 2 diabetes and poor glycemic control who do not currently meet recommended physical activity levels.
Not a fit: Patients who are already engaging in regular exercise or have well-controlled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing exercise regimens for better diabetes management and gut health.
How similar studies have performed: While there is ongoing research into exercise and gut microbiome interactions, this specific approach of comparing high and moderate intensity in type 2 diabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fredericton, New Brunswick
- Cardiometabolic Exercise & Lifestyle Laboratory — Fredericton, New Brunswick, Canada (Recruiting)
Study contacts
- Principal investigator: Martin Senechal, Ph.D. — University of New Brunswick
- Study coordinator: Martin Senechal, Ph.D.
- Email: martin.senechal@unb.ca
- Phone: 506-451-6889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.