Dietary Interventions on Glycocalyx Dimensions in South Asian Patients With Diabetic Nephropathy. (NCT03889236) | Clinical Trial Compass
CompletedNot Applicable
Dietary Interventions on Glycocalyx Dimensions in South Asian Patients With Diabetic Nephropathy.
Netherlands56 participantsStarted 2018-05-03
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
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.
What they're measuring
1
Percentage change from baseline in the Microvascular Health Index in the fasting mimicking diet or food supplement group compared to the placebo group
✕. 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).