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

NCT06281899 | Recruiting Phase 4

• 1 other identifier: 01/2022
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Kidney Diseases; Type 2 Diabetes Mellitus

Keywords

chronic kidney disease; low protein diet; nutrition therapy

Outcome Measures

Primary Outcomes (1)

• Time to the First Occurrence of Any of the Components of the Composite: ≥30% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death

  End Stage Renal Disease (ESRD) is defined as: * Sustained eGFR \<15 mL/min/1.73m2 or, * Chronic dialysis treatment or, * Receiving a kidney transplant

  12 months after randomization

Secondary Outcomes (16)

• Rate of decline in the estimated Glomerular Filtration Rate

  month 3, 9 and12 after randomization

• Variation of albuminuria

  month 3, 9 and12 after randomization

• Variation of HbA1C

  month 3, 9 and12 after randomization

• Variation of serum cholesterol levels

  month 3, 9 and12 after randomization

• Variation of serum bicarbonate levels

  month 3, 9 and12 after randomization

Other Outcomes (3)

• Compliance to the protein intake

  month 1, 3, 9 and12 after randomization

• Compliance to the energy intake

  month 1, 3, 9 and12 after randomization

• Compliance to carbohydrate intake

  month 1, 3, 9 and12 after randomization

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: Dapagliflozin 10 mg Tab; Behavioral: Low protein diet

Control

ACTIVE COMPARATOR

Patients will receive Dapagliflozin 10 mg per day

Drug: Dapagliflozin 10 mg Tab

Interventions

Dapagliflozin 10 mg Tab DRUG

Dapagliflozin 10 mg once daily

Control; Intervention

Low protein diet BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Anemia Working Group Romania: lead
• Sf Ioan Emergency Clinical Hospital, Nephrology and Dialysis Department, Bucharest, Romania: collaborator
• Dr Carol Davila Teaching Hospital of Nephrology, Nephrology Department, Bucharest, Romania: collaborator
• Carol Davila University of Medicine and Pharmacy: collaborator

Study Sites (1)

Carol Davila University of Medicine and Pharmacy Bucharest

Bucharest, Romania

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Interventions

dapagliflozin; Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Liliana Garneata, Professor

  Carol Davila University of Medicine and Pharmacy Bucharest, Romania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liliana Garneata, Professor

CONTACT

+40722619358; lilianagarna@yahoo.com

Elena Cuiban, PhD student

CONTACT

+40748975315; elena.cuiban@drd.umfcd.ro

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: February 28, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)