Comparing supervised and independent physical activity for managing type 2 diabetes
Comparative Effectiveness on Glycemic Balance of a Non-pharmacological Treatment, Adapted Physical Activity (APA), Either Supervised by a Qualified APA Instructor or Unsupervised in Autonomy, in Individuals With Inadequately Controlled Type 2 Diabetes, Under Diet Alone or Non-insulin Treatment.
This study tests whether people with poorly managed type 2 diabetes can better control their blood sugar by doing physical activity on their own or with a trainer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 67 Years |
| Sex | All |
| Sponsor | Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète Academic / other |
| Locations | 1 site (Évry) |
| Trial ID | NCT06598865 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Adapted Physical Activity (APA) in improving glycemic control in individuals with poorly managed type 2 diabetes. Participants will either engage in APA independently after training or under the supervision of a qualified instructor. The study aims to determine which approach leads to better glycemic regulation while participants are on non-insulin treatments. All participants will be monitored using a FitBit Charge 6 to track their physical activity levels throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 67 with poorly controlled type 2 diabetes who are on non-insulin treatments.
Not a fit: Patients who are insulin-dependent or have well-controlled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological approach to better manage glycemic levels in patients with type 2 diabetes.
How similar studies have performed: Previous studies have shown positive outcomes with physical activity interventions for diabetes management, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient who has given consent to participate in the study and has signed an informed consent form. * Patient aged 18 to 67 years * Patient diagnosed with type 2 diabetes * Patient newly diagnosed or on non-insulin treatment (metformin +/- DPP4 inhibitor, GLP1 analogue +/- SGLT2 inhibitor) for whom it is considered to initiate or intensify antidiabetic treatment by introducing a new therapeutic class. * Patient insufficiently controlled (\> 1.30 g/L fasting blood glucose measured in the laboratory twice a few days apart in a city laboratory) * Patient with good venous access. * Patient capable of engaging in regular physical activity * Patient who has undergone a coronary artery disease screening test in the year prior to inclusion according to the new recommendations of an expert consensus. * Patient agrees to wear a FitBit Charge 6 bracelet for the entire duration of the study, including the run-in period, and agrees to recharge it and transmit the data. Exclusion Criteria: * Patient diagnosed with type 1 diabetes * Patient treated with sulfonylureas * Patient with a history of severe cardiovascular diseases (myocardial infarction, acute coronary syndrome, or stroke in the past year) * Patient presenting a medical contraindication to performing a physical activity session (uncontrolled resting hypertension, i.e., systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg, unstable coronary artery disease, heart failure, severe proliferative or non-proliferative evolving retinopathy (unstabilized), or having undergone recent surgical laser treatment of the eye, plantar perforating ulcer, disabling osteoarthritis of the lower limbs, respiratory failure, severe renal impairment, liver failure, severe dysautonomia, i.e., risk of chronotropic insufficiency during exercise, peripheral neuropathy) * Patient with a history of severe hypoglycemia in the 6 months prior to entering the study and/or not feeling their hypoglycemia at all * Patient with an IPAQ score in the high category * Patient with a known latex allergy * Patient with morbid obesity (BMI \> 40 kg/m²) * Other conditions that may interfere with glycemic variation: particularly the use of corticosteroids during the study * Patient treated with beta-blockers or calcium channel blockers with negative chronotropic action (such as isoptin) * Breastfeeding woman * Pregnant woman\* or wishing to become pregnant
Where this trial is running
Évry
- CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète), — Évry, France (Recruiting)
Study contacts
- Study coordinator: Dina INGRAO-LECANTE, Clinical Project Manager
- Email: dina.ingrao-lecante@ceritd.com
- Phone: +33164968639
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.