Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus

Anemia Working Group Romania200 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Chronic Kidney Diseases Type 2 Diabetes Mellitus

Interventions

Dapagliflozin 10 mg TabDRUG

Dapagliflozin 10 mg once daily

Low protein dietBEHAVIORAL

Plant based low protein diet (0.6 g/kg IBW)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Locations (1)

Carol Davila University of Medicine and Pharmacy Bucharest

Bucharest, Romania

RECRUITING

Outcomes

Primary Outcomes

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

End Stage Renal Disease (ESRD) is defined as: * Sustained eGFR \<15 mL/min/1.73m2 or, * Chronic dialysis treatment or, * Receiving a kidney transplant

Time frame: 12 months after randomization