Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| 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 |
Not provided
Not provided
Not provided
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
The KDIGO Diabetes in CKD Guideline (2020) recommends the use of SGLT2i (level 1A) and suggests (level 2C) the prescription of plant protein-based low-protein diet in patients with chronic kidney disease (CKD) and diabetes mellitus (DM). Both interventions have shown synergistic nephroprotective effects, slowing the progression of chronic kidney disease by reducing glomerular hyperfiltration and proteinuria, thus resulting the hypothesis that by combining these two interventions it could be possible to achieve a superior control over the progression of diabetic kidney disease.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control | Active Comparator | Patients will receive Dapagliflozin 10 mg per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10 mg Tab | Drug | Dapagliflozin 10 mg once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of decline in the estimated Glomerular Filtration Rate | Difference between eGFR at any timepoint and the initial eGFR | month 3, 9 and12 after randomization |
| Variation of albuminuria | Difference between albuminuria at at any timepoint and the initial albuminuria (expressed as albumin to creatinine ratio) |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance to the protein intake | Achieved protein intake will be estimated based on urinary urea excretion, using Mitch-Maroni's formula | month 1, 3, 9 and12 after randomization |
| Compliance to the energy intake |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liliana Garneata, Professor | Contact | +40722619358 | lilianagarna@yahoo.com | |
| Elena Cuiban, PhD student | Contact | +40748975315 | elena.cuiban@drd.umfcd.ro |
| Name | Affiliation | Role |
|---|---|---|
| Liliana Garneata, Professor | Carol Davila University of Medicine and Pharmacy Bucharest, Romania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carol Davila University of Medicine and Pharmacy Bucharest | Recruiting | Bucharest | Romania |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Low protein diet |
| Behavioral |
Plant based low protein diet (0.6 g/kg IBW) |
|
| month 3, 9 and12 after randomization |
| Variation of HbA1C | Difference between HbA1C at at any timepoint and the initial HbA1C | month 3, 9 and12 after randomization |
| Variation of serum cholesterol levels | Difference between serum cholesterol at at any timepoint and the initial serum cholesterol | month 3, 9 and12 after randomization |
| Variation of serum bicarbonate levels | Difference between serum bicarbonate at at any timepoint and the initial serum bicarbonate | month 3, 9 and12 after randomization |
| Variation of serum potassium levels | Difference between serum potassium at at any timepoint and the initial serum potassium | month 3, 9 and12 after randomization |
| Variation of serum sodium levels | Difference between serum sodium at at any timepoint and the initial serum sodium | month 3, 9 and12 after randomization |
| Variation of hemoglobin levels | Difference between hemoglobin at at any timepoint and the initial serum hemoglobin | month 3, 9 and12 after randomization |
| Variation of hematocrit levels | Difference between hematocrit at at any timepoint and the initial hematocrit | month 3, 9 and12 after randomization |
| All cause hospitalizations | Percentage of patients who experienced hospitalizations of all cause | 12 months after randomization |
| Variation in body weight | Difference between body weight at at any timepoint and the body weight | month 3, 9 and12 after randomization |
| Variation in BMI | Difference between BMI at at any timepoint and the initial BMI | month 3, 9 and12 after randomization |
| Variation in handgrip strength | Difference between handgrip strength at at any timepoint and the initial handgrip strength | month 3, 9 and12 after randomization |
| Variation in serum albumin levels | Difference between serum albumin at at any timepoint and the initial serum albumin | month 3, 9 and12 after randomization |
| Variation in CRP levels | Difference between CRP at at any timepoint and the initial CRP | month 3, 9 and12 after randomization |
| Changes in the quality of life | Evaluated by SF-36 questionaire | month 3, 9 and12 after randomization |
Achieved energy intake will be estimated using the 3-day food diary to calculate the daily energy intake
| month 1, 3, 9 and12 after randomization |
| Compliance to carbohydrate intake | Achieved energy intake will be estimated by the 3-day food diary to calculate thecarbohydrates intake | month 1, 3, 9 and12 after randomization |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D018753 | Diet, Protein-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided