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Effect of Sodium-Glucose Cotransporter (SGLT) 2 Inhibitors on Diabetic Nephropathy Progression in Adolescents with Type 1 Diabetes Mellitus
Eighty six adolescents with T1D nephropathy according to the ISDAD 2022 guidelines were assigned into two equal groups randomly, one received empagliflozin initiated at 10 mg once daily in addition to their insulin therapy and the other received insulin therapy and placebo. Blood pressure percentiles, urine output, fasting lipids profile, HbA1C and CGM metrics were assessed at baseline, 3 and 6 months of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin | Active Comparator | Empagliflozin 10 mg once daily |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin (EMPA) | Drug | empagliflozin oral once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Nephropathy | Change in the UACR after 6 months from baseline. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic metrics | change in the glycemic metrics after 6 months from baseline | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003928 | Diabetic Nephropathies |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Placebo |
| Other |
placebo |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |