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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01698-35 | Other Identifier | ID-RCB number, ANSM |
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This work will make it possible to identify the nephron loss of type 2 diabetic patients in the western region and to better define in general practice the impact of the elements put in place to reduce this loss and to raise awareness of the importance of these measures through training in comparison with a control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training | Experimental | Physicians participating will receive training on renal failure in type 2 diabetes and on measures to reduce nephron loss |
|
| Routine care | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| training and audit | Other | An evaluation of the practices with clinical audit before and after the management will be carried out.Every 3 months for 2 years, the investigating physicians of the intervention group will report for these patients the modifications or cessation of treatment, modification or implementation of interventions such as physical activity or implementation of nutritional modifications. Physician investigators will be asked to report any occurrence of adverse events to their regional pharmacovigilance centers.10 possible actions to be deployed :
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| Measure | Description | Time Frame |
|---|---|---|
| Change in annual glomerular filtration rate (GFR) slope | the annual glomerular filtration rate (GFR) slope calculated as the difference between the estimated loss over the two years before inclusion (N-2) and the estimated annual loss over the follow-up years after inclusion. | Every 3 months during 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Audit of clinical practices | before randomization, at 6 months and 24 months in the 2 groups | |
| Cumulative incidence of unscheduled hospitalizations for all reasons at 2 years from the start of care in the intervention group compared to the control group |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D007674 | Kidney Diseases |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| Routine care | Other | Physicians in the "control" group will receive training on the study procedures. An evaluation of practices with a clinical audit before and after the treatments will be carried out. Every 3 months for 2 years, the investigating physicians in the control group will report for these patients the modifications or cessation of treatment, the modification or implementation of interventions such as physical activity or the implementation of modifications in terms of nutrition. The investigating physicians will be asked to report any occurrence of adverse events to their regional pharmacovigilance centers. Physician investigators in the control group will continue their care as usual. |
|
| At 2 years (the end of the study) |
| change of Albuminuria | at baseline and every 3 months during the 2-year follow-up. |
| D052801 | Male Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |