Low protein diet combined with dapagliflozin for chronic kidney disease in type 2 diabetes patients
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
This study is testing if a low protein diet combined with the medication dapagliflozin can help people with type 2 diabetes and chronic kidney disease slow down their kidney problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Anemia Working Group Romania Academic / other |
| Locations | 1 site (Bucharest) |
| Trial ID | NCT06281899 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with confirmed chronic kidney disease and type 2 diabetes, stable kidney function, and good compliance with dietary recommendations.
Not a fit: Patients with severely impaired kidney function (eGFR < 25 ml/min/1.73 m2) or poorly controlled blood pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly slow the progression of chronic kidney disease in patients with type 2 diabetes, improving their overall health outcomes.
How similar studies have performed: Previous studies have shown promising results with similar dietary and pharmacological interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bucharest
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.