Effect of the Low PROtein Diet on Top of DAPAgliflozin and RAASi on the Progression of Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time to the First Occurrence of Any of the Components of the Composite: ≥30% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death
研究概览
简要总结
This is a prospective multicenter randomized controlled trial with a total duration of 36 months aiming to evaluate the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and renin-angiotensin-aldosterone inhibitors (RAASi) in reducing the progression of chronic kidney disease in patients with type 2 Diabetes Mellitus
详细描述
The KDIGO Diabetes in CKD Guideline (2020) recommends the use of SGLT2i (level 1A) and suggests (level 2C) the prescription of plant protein-based low-protein diet in patients with chronic kidney disease (CKD) and diabetes mellitus (DM). Both interventions have shown synergistic nephroprotective effects, slowing the progression of chronic kidney disease by reducing glomerular hyperfiltration and proteinuria, thus resulting the hypothesis that by combining these two interventions it could be possible to achieve a superior control over the progression of diabetic kidney disease.
The nutritional intervention will consist in a mild protein restriction (0.6 g/kg dry ideal body weight) and a total recommended energy intake of 30-35 kcal/kg of ideal dry body weight per day in all patients. The protein intake will be checked through the food diary and calculated based on urea from 24 hours urine collection.
The efficacy and safety parameters will be evaluated during follow-up visits at month 1,2,3,6,12 and 18.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age>18 years old
- •confirmed chronic kidney disease (with eGFR between 60 and 20 ml/min/1.73 m2 and/or proteinuria >500 mg/g urinary creatinine) and confirmed type 2 Diabetes Mellitus
- •stable kidney function for at least 12 weeks before enrollment (defined as decrease in eGFR < 5 ml/min/1.73 m2/year according to KDIGO 2012 guideline)
- •treatment with ACE/ARBs and/or MRAs for at least 3 months
- •no previous treatment with SGLT2i
- •good nutritional status
- •declared and anticipated good compliance with the prescribed diet
- •signed informed consent
排除标准
- •eGFR < 25 ml/min/1.73 m2
- •poorly controlled arterial blood pressure (mean BP≥145/85 mm Hg)
- •class IV NYHA heart failure, recent MACE (less than 6 months)
- •relevant comorbid conditions (active infections (HBV, HCV, HIV), active neoplasia, digestive diseases with malabsorption, active autoimmune diseases/ immunosuppressive therapy)
- •kidney transplantation with functional graft
- •malnutrition: BMI<18 kg/me, eight loss >10% during the last 6 months, serum albumin <3 g/dL
- •feeding inability (anorexia, nausea)
研究组 & 干预措施
Intervention
Patients will receive a plant-based low protein diet (0.6 g proteins/kg ideal body weight per day) associated with Dapagliflozin 10 mg per day
干预措施: Dapagliflozin 10 mg Tab (Drug)
Intervention
Patients will receive a plant-based low protein diet (0.6 g proteins/kg ideal body weight per day) associated with Dapagliflozin 10 mg per day
干预措施: Low protein diet (Behavioral)
Control
Patients will receive Dapagliflozin 10 mg per day
干预措施: Dapagliflozin 10 mg Tab (Drug)
结局指标
主要结局
Time to the First Occurrence of Any of the Components of the Composite: ≥30% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death
时间窗: 12 months after randomization
End Stage Renal Disease (ESRD) is defined as: * Sustained eGFR \<15 mL/min/1.73m2 or, * Chronic dialysis treatment or, * Receiving a kidney transplant
次要结局
- Rate of decline in the estimated Glomerular Filtration Rate(month 3, 9 and12 after randomization)
- Variation of albuminuria(month 3, 9 and12 after randomization)
- Variation of HbA1C(month 3, 9 and12 after randomization)
- Variation of serum bicarbonate levels(month 3, 9 and12 after randomization)
- Variation in body weight(month 3, 9 and12 after randomization)
- Variation of serum sodium levels(month 3, 9 and12 after randomization)
- Variation of hematocrit levels(month 3, 9 and12 after randomization)
- All cause hospitalizations(12 months after randomization)
- Variation in BMI(month 3, 9 and12 after randomization)
- Variation in handgrip strength(month 3, 9 and12 after randomization)
- Variation of serum cholesterol levels(month 3, 9 and12 after randomization)
- Variation in serum albumin levels(month 3, 9 and12 after randomization)
- Variation in CRP levels(month 3, 9 and12 after randomization)
- Changes in the quality of life(month 3, 9 and12 after randomization)
- Variation of serum potassium levels(month 3, 9 and12 after randomization)
- Variation of hemoglobin levels(month 3, 9 and12 after randomization)