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

Sponsor
Anemia Working Group Romania
Study ID
NCT06281899
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 mg Tab — DRUG
    Dapagliflozin 10 mg once daily
  • Low protein diet — BEHAVIORAL
    Plant based low protein diet (0.6 g/kg IBW)

Study Details

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

Key Dates

Start date
Jan 1, 2022
Status verified
Feb 2024
Primary completion
Dec 31, 2024
Completion
Mar 31, 2025

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Active Comparator: Control
    Patients will receive Dapagliflozin 10 mg per day

Primary Outcome Measure

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 [ Time Frame: 12 months after randomization ]

Central Contacts

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