Nephropathy, Diabetic, Type 1 Diabetes
Conditions
Keywords
SGLT2 inhibitors, type 1 diabetes, adolescents, Nephropathy
Brief summary
Effect of Sodium-Glucose Cotransporter (SGLT) 2 Inhibitors on Diabetic Nephropathy Progression in Adolescents with Type 1 Diabetes Mellitus
Detailed description
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.
Interventions
empagliflozin oral once daily
OTHERPlacebo
placebo
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients with T1DM according to the international society of pediatric and adolescent diabetes (ISPAD). (Couper et al., ISPAD 2022). * Age 10- 18 years old. * Diabetic nephropathy according to ISPAD. (Couper et al., ISPAD 2022). * eGFR \> 30 ml/min per 1.73 m2
Exclusion criteria
* Patient with other types of diabetes e.g. T2DM, maturity onset diabetes of the young (MODY). * Presence of contraindication for empagliflozin e.g. History of serious hypersensitivity reaction to empagliflozin, end-stage renal disease, or dialysis. * Other types of nephropathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nephropathy | 6 months | Change in the UACR after 6 months from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic metrics | 6 months | change in the glycemic metrics after 6 months from baseline |
Countries
Egypt
Outcome results
None listed