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The sponsor has temporarily suspended participant enrollment due to operational constraints impacting study implementation. This decision is not related to safety concerns. The study is expected to resume once the identified issues are addressed.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adapted physical activity | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measurement of glucose by CGM | 10 days after 3-month re-training program |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète), | Évry | 91058 | France |
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|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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