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

Sponsor

Leiden University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03889236

Collaborator

Dutch Kidney Foundation (Other), Health Holland (Other), Radboud University Medical Center (Other)

Enrollment

Location

Arms

28.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathy Type 2 Albuminuria Type2 Diabetes Mellitus Glucose Metabolism Disorders Microalbuminuria Diabetic Nephropathies Diabetic Complications Renal Diabetes Mellitus Kidney Diseases South Asian	Other: Fasting mimicking diet Prolon Dietary Supplement: Food supplement Endocalyx Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients are randomized into the diet group, food supplement group or placebo group. The placebo and foodsupplement groups are double blinded.Patients are randomized into the diet group, food supplement group or placebo group. The placebo and foodsupplement groups are double blinded.

Masking:

Double (Participant, Investigator)

Masking Description:

The placebo and food supplement groups are double blinded.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 3, 2018

Actual Primary Completion Date :

Sep 9, 2020

Actual Study Completion Date :

Sep 9, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Fasting mimicking diet

5-day Fasting mimicking diet Prolon. In total 3 cycles of the FMD in three months.

Other: Fasting mimicking diet Prolon

5-day fasting mimicking diet

Other Names:

FMD

Prolon

L-Nutra

Experimental: Food supplement

4 capsules a day of the food supplement Endocalyx for 3 months.

Dietary Supplement: Food supplement Endocalyx

Food supplement

Other Names:

Endocalyx

Q-prime

Placebo Comparator: Placebo

4 capsules a day of the placebo for 3 months.

Dietary Supplement: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.