Dietary Interventions on Glycocalyx Dimensions in South Asian Patients With Diabetic Nephropathy.

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Dietary Interventions on Endothelial Glycocalyx Dimensions and Barrier Function in South Asian Patients With Diabetic Nephropathy.

Conditions
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Diabetic Nephropathy Type 2, Albuminuria, Type2 Diabetes Mellitus, Glucose Metabolism Disorders, Microalbuminuria, Diabetic Nephropathies, Diabetic Complications Renal, Diabetes Mellitus, Kidney Diseases, South Asian

Intervention / Treatment
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* Other: Fasting mimicking diet Prolon
* Dietary Supplement: Food supplement Endocalyx
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: South Asian patient with diabetes mellitus type 2. Female or male, aged between 18 and 75 years. Body Mass Index ≥18.5. CKD-EPI >45 ml/min/1.73m² . 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. Systolic blood pressure ≤ 180 mmHg. Treatment with hypoglycemic drugs: metformin, sulphonylureas and/or insulin. 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. Patients must be able to adhere to the study visit schedule and protocol requirements. If female and of child-bearing age, patients must be non-pregnant, non-breastfeeding, and use adequate contraception. 4.3 Exclusion Exclusion Criteria: 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. Non-diabetic renal disease e.g. known polycystic kidney disease. Use of LMW heparin and/or immunosuppressive drugs. Significant food allergies for galactose, nuts, soy, tomato, corn, grape, melon and artichoke, which would make the subject unable to consume the food provided. Signs of active infection or autoimmune disease, requiring systemic treatment. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. 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). Use of any other investigational drug. Patient has enrolled another clinical trial within last 4 weeks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized into the diet group, food supplement group or placebo group. The placebo and foodsupplement groups are double blinded.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting mimicking diet<br>5-day Fasting mimicking diet Prolon. In total 3 cycles of the FMD in three months. | Other: Fasting mimicking diet Prolon<br>* 5-day fasting mimicking diet<br>* Other names: L-Nutra;|
| Experimental: Food supplement<br>4 capsules a day of the food supplement Endocalyx for 3 months. | Dietary Supplement: Food supplement Endocalyx<br>* Food supplement<br>* Other names: Q-prime;|
| Placebo Comparator: Placebo<br>4 capsules a day of the placebo for 3 months. | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |