Type 2 Diabetes (T2D) Clinical Trials

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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.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 67
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète),
RECRUITING
Évry
Contact Information
Primary
Dina INGRAO-LECANTE, Clinical Project Manager
dina.ingrao-lecante@ceritd.com
+33164968639
Backup
Hicham Kacimi, Clinical Project Manager
hicham.kacimi@ceritd.com
+33164966361
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2028-06
Participants
Target number of participants: 120
Treatments
No_intervention: control
after initial APA training, patients will be asked to implement APA sessions on their own for the duration of the study. They will then be asked to return to the investigating center for a visit at 3 months (Visit 3) to assess the effect of the APA carried out during this period.
Experimental: experimental
after initial APA training, patients will receive regular support from an APA teacher, and will be asked to carry out 3 APA sessions a week, if possible in a Sport-Santé centre close to their home, for the duration of the study. The content of additional APA sessions (up to 2 additional sessions per week) can be discussed with the APA teacher.~They will also be asked to return to the investigating center for a visit at 3 months (Visit 3) to assess the effect of the APA carried out during this period.
Related Therapeutic Areas
Sponsors
Leads: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

This content was sourced from clinicaltrials.gov