Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
- Conditions
- Chronic Kidney DiseasesType 2 Diabetes Mellitus
- Interventions
- Behavioral: Low protein diet
- Registration Number
- NCT06281899
- Lead Sponsor
- Anemia Working Group Romania
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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)
- ADPKD
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Dapagliflozin 10 mg Tab Patients will receive Dapagliflozin 10 mg per day Intervention Low protein diet 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 Intervention Dapagliflozin 10 mg Tab 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
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method Rate of decline in the estimated Glomerular Filtration Rate month 3, 9 and12 after randomization Difference between eGFR at any timepoint and the initial eGFR
Variation of albuminuria month 3, 9 and12 after randomization Difference between albuminuria at at any timepoint and the initial albuminuria (expressed as albumin to creatinine ratio)
Variation of HbA1C month 3, 9 and12 after randomization Difference between HbA1C at at any timepoint and the initial HbA1C
Variation of serum bicarbonate levels month 3, 9 and12 after randomization Difference between serum bicarbonate at at any timepoint and the initial serum bicarbonate
Variation of serum sodium levels month 3, 9 and12 after randomization Difference between serum sodium at at any timepoint and the initial serum sodium
Variation of hematocrit levels month 3, 9 and12 after randomization Difference between hematocrit at at any timepoint and the initial hematocrit
All cause hospitalizations 12 months after randomization Percentage of patients who experienced hospitalizations of all cause
Variation of serum cholesterol levels month 3, 9 and12 after randomization Difference between serum cholesterol at at any timepoint and the initial serum cholesterol
Variation in body weight month 3, 9 and12 after randomization Difference between body weight at at any timepoint and the body weight
Variation in BMI month 3, 9 and12 after randomization Difference between BMI at at any timepoint and the initial BMI
Variation in handgrip strength month 3, 9 and12 after randomization Difference between handgrip strength at at any timepoint and the initial handgrip strength
Variation in serum albumin levels month 3, 9 and12 after randomization Difference between serum albumin at at any timepoint and the initial serum albumin
Variation in CRP levels month 3, 9 and12 after randomization Difference between CRP at at any timepoint and the initial CRP
Changes in the quality of life month 3, 9 and12 after randomization Evaluated by SF-36 questionaire
Variation of serum potassium levels month 3, 9 and12 after randomization Difference between serum potassium at at any timepoint and the initial serum potassium
Variation of hemoglobin levels month 3, 9 and12 after randomization Difference between hemoglobin at at any timepoint and the initial serum hemoglobin
Trial Locations
- Locations (1)
Carol Davila University of Medicine and Pharmacy Bucharest
🇷🇴Bucharest, Romania