An interventional study of High intensity and Moderate intensity in Type 2 Diabetes, sponsored by University of New Brunswick. Completed at 1 site in Canada. Open to participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of New Brunswick · Not applicable, Interventional, and Prevention
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of New Brunswick is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will perform high-intensity aerobic and strength training exercises.
Other: High intensity
Participants will perform moderate-intensity aerobic and strength training exercises.
Other: Moderate intensity
High intensity exercise
Moderate intensity exercise
Glycemic control through glycated hemoglobin
Change in glycated hemoglobin (HbA1c)
Time frame: 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
Time frame: 16 weeks
Ran from Feb 2024 to primary completion in Apr 2026, 25 months.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 25 months is above that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of New Brunswick