NCT06562842Recruiting
Exercise, Gut Microbiota and Type 2 Diabetes
The Effects of Regular Exercise on Gut Microbiota Composition in Individuals with Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 28 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This randomized, parallel, controlled study, will investigate the effect of regular exercise on GM composition, inflammatory status, and insulin sensitivity, in the progression from normal glucose tolerance (NGT), to prediabetes (pre-D), to type 2 diabetes (T2D). Following baseline assessment of glucose tolerance, the participants will be randomly assigned to either a 12-week, thrice-weekly exercise training program followed by 4 weeks of detraining, or will remain sedentary for the 16-week intervention. Thus, the six study groups will be: 1) NGT group (NGT), NGT individuals - no exercise, 2) NGT exercise group (NGT+Ex), NGT individuals that will participate in training and detraining, 3) pre-D group (pre-D), pre-D individuals - no exercise, 4) pre-D exercise group (Pre-D+Ex), pre-D individuals that will participate in training and detraining, 5) T2D group (T2D), T2D individuals - no exercise, and 6) T2D exercise group (T2D+Ex), T2D individuals that will participate in training and detraining. Assessment of physiological measures, anthropometric characteristics, body composition, glucose tolerance, insulin sensitivity, complete blood count, lipidemic profile, GM composition, inflammatory status, oxidative stress, and muscle performance, will be conducted before and following 12 weeks of the exercise training intervention and following 4 weeks of detraining for all participants.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 10 Aug 2024
- Start date
- 10 Mar 2025
- Primary completion date
- 30 May 2026
- Lead sponsor
- University of Thessaly
- Diseases
- Type 2 diabetes
- NCT number
- NCT06562842
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 10 Mar 2025 to the primary completion date, 30 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Consumption of anti-inflammatory drugs and/or antibiotics and/or dietary supplements that could affect GM composition before the study (\<3 months)
Other illness
- Other chronic diseases ot recent history of musculoskeletal injury (\<6 months)
Age
- Age \<45 years or \>65 years
Other
- Physically active individuals
Who the study is looking for
- Age between 45 and 65 years old
- Sedentary lifestyle or insufficient daily physical activity according to guidelines for T2D
- Abstinence of anti-inflammatory drugs and/or antibiotics and/or dietary supplements that could affect GM composition before the study (\>3 months)
- No other chronic diseases and/or musculoskeletal injuries (\>6 months)
Age in the registry: 45 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Physical Education and Sport Science, Uninersity of Thessaly Coordinator of this site? Confirm its status | Trikala | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.