RecruitingNot ApplicableNCT06598865

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.

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.


Sponsor

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Enrollment

120 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 67 Years

Plain Language Summary

Simplified for easier understanding

This French study is comparing two ways of delivering adapted physical activity (APA) — a medically-prescribed exercise program — for people with poorly controlled type 2 diabetes: independently (after initial training) versus supervised by an exercise therapist, to see which better improves blood sugar control. **You may be eligible if...** - You are between 18 and 67 years old - You have been diagnosed with type 2 diabetes - Your blood sugar is poorly controlled (fasting glucose above 1.30 g/L on two tests) - You are currently on non-insulin medications (such as metformin, DPP4 inhibitors, GLP1 analogues, or SGLT2 inhibitors) - You are capable of doing regular physical activity - You are willing to wear a fitness tracker for the full study **You may NOT be eligible if...** - You have type 1 diabetes - You had a heart attack, stroke, or acute coronary event in the past year - You have severe cardiovascular conditions, proliferative eye disease (retinopathy), severe kidney or liver disease, or disabling joint problems in the lower limbs - You are pregnant or breastfeeding - You have had severe low blood sugar episodes recently - Your BMI is above 40 kg/m2 (morbid obesity) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERadapted physical activity

After the initial training in adapted physical activity (APA), patients will receive regular support from an APA instructor, and they will be asked to participate in 3 sessions per week of APA, if possible in a Sport-Health center close to their home, for the entire duration of the study. The content of the additional APA sessions (up to 2 additional sessions per week) can be discussed with the APA instructor. They will also be asked to return to the study center for a visit at 3 months (Visit 3) to assess the effect of the APA conducted during this period


Locations(1)

CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète),

Évry, France

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NCT06598865