Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT06281899
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2022-01-01
2025-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Dapagliflozin 10 mg Tab
Dapagliflozin 10 mg once daily
Low protein diet
Plant based low protein diet (0.6 g/kg IBW)
Control
Patients will receive Dapagliflozin 10 mg per day
Dapagliflozin 10 mg Tab
Dapagliflozin 10 mg once daily
Interventions
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Dapagliflozin 10 mg Tab
Dapagliflozin 10 mg once daily
Low protein diet
Plant based low protein diet (0.6 g/kg IBW)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Sf Ioan Emergency Clinical Hospital, Nephrology and Dialysis Department, Bucharest, Romania
UNKNOWN
Dr Carol Davila Teaching Hospital of Nephrology, Nephrology Department, Bucharest, Romania
UNKNOWN
Carol Davila University of Medicine and Pharmacy
OTHER
Anemia Working Group Romania
OTHER
Responsible Party
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Principal Investigators
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Liliana Garneata, Professor
Role: PRINCIPAL_INVESTIGATOR
Carol Davila University of Medicine and Pharmacy Bucharest, Romania
Locations
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Carol Davila University of Medicine and Pharmacy Bucharest
Bucharest, , Romania
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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01/2022
Identifier Type: -
Identifier Source: org_study_id
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