Chronic Kidney Disease (CKD)
Conditions
Interventions
Dietary intervention
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >18 years- Presence of T2D and CKD stage G1-3a with albuminuria (>10mg/mmol)- BMI= 25kg/m2- Use of metformin on a stable dose (i.e. no changes in the last three months)- Adequate knowledge of the Dutch language to comprehend the provided study information- If incretin therapy is used, then subject must have used that for a minimum of 6 months before starting with the trial- use of ACE inhibitors or angiotensin II receptor blockers- Of white Dutch or South-Asian Surinamese descent-Dietary Acid Load = 40 mEq H+/day at baseline measured via food records
Exclusion criteria
Exclusion criteria: - Use of insulin- serum bicarbonate < 20 mmol/L- Use of antibiotics 3 months before inclusion- Vegetarian diet- Presence of inflammatory bowel disease or other chronic inflammatory disease- Alcohol consumption of more than 14 units per week in women, or more than 21 units per week in men- Active malignancy- bariatric or other weight loss surgery in the history- patients diagnosed with eating disorders (such as bulimia nervosa, anorexia nervosa or binge-eating disorder)- HbA1c >9% (75mmol/mol)- Unmotivated or not able to adhere to a specific diet.- The subject is already currently involved in a clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Percentage change in urinary albumin:creatinine ratio after 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Changes in eGFR, kidney damage markers (uNAG, uNGAL), acid-base status (serum bicarbonate, urinary citrate, pH), glucose metabolism (OGTT, HOMA-IR, CGM), gut microbiota composition, and serum metabolome | — |
Countries
Netherlands
Contacts
Public ContactI Attaye
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed