diabetic kidney damage diabetic nephropathy
Conditions
Interventions
One group receives a monthly 5-day fasting mimicking diet for 3 consecutive
months, one group receives daily 4 capsules of a food supplement and one group
receives daily 4 placebo capsules, all for
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. South Asian patient with diabetes mellitus type 2. 2. Female or male, aged between 18 and 75 years. 3. Body Mass Index *18.5. 4. CKD-EPI >45 ml/min/1.73m² at baseline. 5. Proven microalbuminuria defined as albumin/creatinine ratio *0.3 and
Exclusion criteria
Exclusion criteria: 1. Any concurrent illness, disability or clinically significant abnormality that may, as judged by the investigator, affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol. 2. Non-diabetic renal disease e.g. known polycystic kidney disease. 3. Use of LMW heparin and/or immunosuppressive drugs. 4. Significant food allergies for galactose, nuts, soy, tomato, corn, grape, melon and artichoke, which would make the subject unable to consume the food provided. 5. Signs of active infection or autoimmune disease, requiring systemic treatment. 6. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. 7. Malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence). 8. Use of any other investigational drug. 9. Patient has enrolled another clinical trial within last 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is an improvement of the Microvascular Health index in the diet group compared to the placebo group, and in the food supplement group compared to the placebo group, after 3 months of the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: reduce albuminuria, decrease inflammation (urinary heparanase and MCP-1 expression, serum CRP and MCP-1 levels), reduce occurrence of specific urinary HS domains, improve metabolic parameters; fasting glucose, HbA1c, C-peptide, IGF-1, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides serum levels, waist circumference, waist-to-hip ratio, body weight and systolic blood pressure after 3 months of the fasting mimicking diet and after 3 months of the food supplement. The legacy effect of the interventions is also determined, 3 months after stopping with the intervention. | — |
Countries
Netherlands
Outcome results
None listed