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

NCT06268743 | Completed

• 1 other identifier: 2023-114
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes

Keywords

Exercise intensity; Aerobic training; Resistance training; Gut microbiome; Physical activity; Glycemia; Diabetes

Outcome Measures

Primary Outcomes (2)

• Glycemic control through glycated hemoglobin

  Change in glycated hemoglobin (HbA1c)

  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

  16 weeks

Study Arms (2)

High intensity

EXPERIMENTAL

Participants will perform high-intensity aerobic and strength training exercises.

Other: High intensity

Moderate Intensity

ACTIVE COMPARATOR

Participants will perform moderate-intensity aerobic and strength training exercises.

Other: Moderate intensity

Interventions

High intensity OTHER

High intensity exercise

High intensity

Moderate intensity OTHER

Moderate intensity exercise

Moderate Intensity

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Brunswick: lead
• Laval University: collaborator

Study Sites (1)

Cardiometabolic Exercise & Lifestyle Laboratory

Fredericton, New Brunswick, E3B5A3, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Martin Senechal, Ph.D.

  University of New Brunswick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Martin Senechal, Ph.D.

Model Details: Parallel group, single blinded, randomized trial

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: February 29, 2024
• Primary Completion: April 7, 2026
• Study Completion: April 7, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CA (1)