The effect of dietary interventions on endothelial glycocalyx dimensions and barrier function in South Asian patients with diabetic nephropathy.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

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 <30
mg/mmol (single portion) or 3-300 mg albumin per day (24 hours urine
collection) in the last twelve months.
6. Blood pressure of *180 mmHg with standard antihypertensive care.
7. Treatment with hypoglycaemic 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.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is an improvement of the Microvascular Health index in the<br /><br>diet group compared to the placebo group, and in the food supplement group<br /><br>compared to the placebo group, after 3 months of the intervention. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: reduce albuminuria, decrease inflammation (urinary<br /><br>heparanase and MCP-1 expression, serum CRP and MCP-1 levels), reduce<br /><br>occurrence of specific urinary HS domains, improve metabolic parameters;<br /><br>fasting glucose, HbA1c, C-peptide, IGF-1, total cholesterol, LDL cholesterol,<br /><br>HDL cholesterol, and triglycerides serum levels, waist circumference,<br /><br>waist-to-hip ratio, body weight and systolic blood pressure after 3 months of<br /><br>the fasting mimicking diet and after 3 months of the food supplement. The<br /><br>legacy effect of the interventions is also determined, 3 months after stopping<br /><br>with the intervention. </p><br>