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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Romania
Carol Davila University of Medicine and Pharmacy Bucharest
RECRUITING
Bucharest
Contact Information
Primary
Liliana Garneata, Professor
lilianagarna@yahoo.com
+40722619358
Backup
Elena Cuiban, PhD student
elena.cuiban@drd.umfcd.ro
+40748975315
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 200
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Carol Davila University of Medicine and Pharmacy, Dr Carol Davila Teaching Hospital of Nephrology, Nephrology Department, Bucharest, Romania, Sf Ioan Emergency Clinical Hospital, Nephrology and Dialysis Department, Bucharest, Romania
Leads: Anemia Working Group Romania

This content was sourced from clinicaltrials.gov