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

NCT06281899 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-02-28

No results posted yet for this study

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

Conditions

Interventions

DRUG

Dapagliflozin 10 mg Tab

Dapagliflozin 10 mg once daily

BEHAVIORAL

Low protein diet

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

Sponsors & Collaborators

  • Sf Ioan Emergency Clinical Hospital, Nephrology and Dialysis Department, Bucharest, Romania

    collaborator UNKNOWN

  • Dr Carol Davila Teaching Hospital of Nephrology, Nephrology Department, Bucharest, Romania

    collaborator UNKNOWN

  • Carol Davila University of Medicine and Pharmacy

    collaborator OTHER

  • Anemia Working Group Romania

    lead OTHER

Principal Investigators

  • Liliana Garneata, Professor · Carol Davila University of Medicine and Pharmacy Bucharest, Romania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06281899 on ClinicalTrials.gov