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

Leiden University Medical Center1 site in 1 country56 target enrollmentMay 3, 2018

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Nephropathy Type 2
Sponsor: Leiden University Medical Center
Enrollment: 56
Locations: 1
Primary Endpoint: Percentage change from baseline in the Microvascular Health Index in the fasting mimicking diet or food supplement group compared to the placebo group
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 3, 2018

End Date

September 9, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Leiden University Medical Center

Responsible Party

Principal Investigator

AnoukvanderVelden

Msc.

Leiden University Medical Center

Eligibility Criteria

Inclusion Criteria

•South Asian patient with diabetes mellitus type
•Female or male, aged between 18 and 75 years.
•Body Mass Index ≥18.
•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.

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.

Outcomes

Primary Outcomes

Percentage change from baseline in the Microvascular Health Index in the fasting mimicking diet or food supplement group compared to the placebo group

Time Frame: 3 months

Secondary Outcomes

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)
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 Urine albumin-to-creatinine ratio (UACR) in the fasting mimicking diet or food supplement group compared to the placebo(3 months)