Albuminuria, Diabetes Mellitus, Diabetic Complications Renal, Diabetic Nephropathies, Diabetic Nephropathy Type 2, Glucose Metabolism Disorders, Kidney Diseases, Microalbuminuria, South Asian, Type2 Diabetes Mellitus
Conditions
Brief summary
Evaluate the effect of a fasting mimicking diet and a food supplement on the microvascular health and urinary heparanase levels in South Asian type 2 diabetic patients with albuminuria.
Interventions
OTHERFasting mimicking diet Prolon
5-day fasting mimicking diet
DIETARY_SUPPLEMENTFood supplement Endocalyx
Food supplement
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Dutch Kidney Foundation
Health Holland
Radboud University Medical Center
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The placebo and food supplement groups are double blinded.
Intervention model description
Patients are randomized into the diet group, food supplement group or placebo group. The placebo and foodsupplement groups are double blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 . 5. Proven microalbuminuria defined as albumin/creatinine ratio ≥0.3 and \<30 mg/mmol (single portion) or 3-300 mg albumin per day (24 hours urine collection) in the last twelve months. 6. Systolic blood pressure ≤ 180 mmHg. 7. Treatment with hypoglycemic drugs: metformin, sulphonylureas and/or insulin. 8. Subject is willing to participate in the study, must be able to give informed consent and the consent must be obtained prior to any study procedure. 9. Patients must be able to adhere to the study visit schedule and protocol requirements. 10. If female and of child-bearing age, patients must be non-pregnant, non-breastfeeding, and use adequate contraception. 4.3 Exclusion
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 |
|---|---|
| Percentage change from baseline in the Microvascular Health Index in the fasting mimicking diet or food supplement group compared to the placebo group | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) in the fasting mimicking diet or food supplement group compared to the placebo | 3 months |
| Percentage change from baseline in urinary heparanase levels in the fasting mimicking diet or food supplement group compared to the placebo | 3 months |
| Percentage change from baseline in urinary MCP-1 levels in the fasting mimicking diet or food supplement group compared to the placebo | 3 months |
| Percentage change from baseline in specific urinary heparan sulfate domains in the fasting mimicking diet or food supplement group compared to the placebo | 3 months |
Countries
Netherlands
Outcome results
None listed