Clinical trial NCT03889236: Dietary Interventions on Glycocalyx Dimensions in South Asian Patients With Diabetic Nephropathy.
Official title: The Effect of Dietary Interventions on Endothelial Glycocalyx Dimensions and Barrier Function in South Asian Patients With Diabetic Nephropathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Nephropathy Type 2
Albuminuria
Type2 Diabetes Mellitus
Glucose Metabolism Disorders
Microalbuminuria
Diabetic Nephropathies
Diabetic Complications Renal
Diabetes Mellitus
Kidney Diseases
South Asian
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Kidney Foundation
name: Health Holland
name: Radboud University Medical Center
First posted: 2019-03-26
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized into the diet group, food supplement group or placebo group. The placebo and foodsupplement groups are double blinded.
Primary purpose: TREATMENT

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.


Eligibility 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 .
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.

Primary outcomes:
measure: Percentage change from baseline in the Microvascular Health Index in the fasting mimicking diet or food supplement group compared to the placebo group
timeFrame: 3 months
Secondary outcomes:
measure: Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) in the fasting mimicking diet or food supplement group compared to the placebo
timeFrame: 3 months
measure: Percentage change from baseline in urinary heparanase levels in the fasting mimicking diet or food supplement group compared to the placebo
timeFrame: 3 months
measure: Percentage change from baseline in urinary MCP-1 levels in the fasting mimicking diet or food supplement group compared to the placebo
timeFrame: 3 months
measure: Percentage change from baseline in specific urinary heparan sulfate domains in the fasting mimicking diet or food supplement group compared to the placebo
timeFrame: 3 months
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden Universitiy Medical Center (LUMC)
state: Noord Holland
Study officials:
affiliation: Leiden University Medical Center
name: Ton J. Rabelink, Prof.
role: PRINCIPAL_INVESTIGATOR
References: