Effect of Sodium-Glucose Cotransporter (SGLT) 2 Inhibitors on Diabetic Nephropathy Progression in Adolescents With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Nephropathy
研究概览
简要总结
Effect of Sodium-Glucose Cotransporter (SGLT) 2 Inhibitors on Diabetic Nephropathy Progression in Adolescents with Type 1 Diabetes Mellitus
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Empagliflozin
Empagliflozin 10 mg once daily
干预措施: Empagliflozin (EMPA) (Drug)
Placebo
placebo
干预措施: Placebo (Other)
结局指标
主要结局
Nephropathy
时间窗: 6 months
Change in the UACR after 6 months from baseline.
次要结局
- Glycemic metrics(6 months)
研究者
Nouran yousef
Associate professor and manager of the pediatric diabetes, endocrinology and metabolism unit
Ain Shams University