Low protein diet combined with dapagliflozin for chronic kidney disease in type 2 diabetes patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized controlled trial aims to evaluate the effectiveness and safety of a low protein diet alongside dapagliflozin in patients with chronic kidney disease and type 2 diabetes mellitus over a 36-month period. The study will assess how this combined approach can slow the progression of kidney disease by reducing glomerular hyperfiltration and proteinuria. Participants will follow a mild protein restriction diet while receiving dapagliflozin, with regular follow-up visits to monitor efficacy and safety parameters. The nutritional intake will be tracked through food diaries and urine tests.

Why it matters

Who can join: the full rules

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)

Where it's running

• Carol Davila University of Medicine and Pharmacy Bucharest
  Bucharest, Romania Recruiting

Study contacts

• Principal investigator: Liliana Garneata, Professor — Carol Davila University of Medicine and Pharmacy Bucharest, Romania
• Study coordinator: Liliana Garneata, Professor
• Email: lilianagarna@yahoo.com
• Phone: +40722619358

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.