Comparative Effectiveness of Prescribed Adapted Physical Activity (APA), Either Practiced Indepen… (NCT06598865) | Clinical Trial Compass
RecruitingNot Applicable
Comparative Effectiveness of Prescribed Adapted Physical Activity (APA), Either Practiced Independently After Training, or Supervised by an APA Teacher, on Glycemic Regulation in People With Unbalanced Type 2 Diabetes.
France120 participantsStarted 2025-02-24
Plain-language 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.
Who can participate
Age range18 Years – 67 Years
SexALL
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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, …
What they're measuring
1
Evaluate the efficacy of a 3-month re-training program, by comparing glycemic averages (measured for 10 consecutive days at 3 months, by a continuous glucose monitoring device (CGM) between experimental group (APA) vs control group.
Timeframe: 10 days after 3-month re-training program
Trial details
NCT IDNCT06598865
SponsorCentre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète