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

Primary Purpose

Diabetic Nephropathy Type 2, Albuminuria, Type2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Fasting mimicking diet Prolon

Food supplement Endocalyx

Placebo

About this trial

This is an interventional treatment trial for Diabetic Nephropathy Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Leiden Universitiy Medical Center (LUMC)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Fasting mimicking diet

Food supplement

Placebo

Arm Description

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

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

4 capsules a day of the placebo for 3 months.

Outcomes

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

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

Percentage change from baseline in urinary heparanase levels in the fasting mimicking diet or food supplement group compared to the placebo

Percentage change from baseline in urinary MCP-1 levels in the fasting mimicking diet or food supplement group compared to the placebo

Percentage change from baseline in specific urinary heparan sulfate domains in the fasting mimicking diet or food supplement group compared to the placebo

Full Information

NCT ID

NCT03889236

First Posted

March 15, 2019

Last Updated

February 17, 2021

Sponsor

Leiden University Medical Center

Collaborators

Dutch Kidney Foundation, Health Holland, Radboud University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03889236

Brief Title

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

Acronym

Glycotreat

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

May 3, 2018 (Actual)

Primary Completion Date

September 9, 2020 (Actual)

Study Completion Date

September 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Leiden University Medical Center

Collaborators

Dutch Kidney Foundation, Health Holland, Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigator

Masking Description

The placebo and food supplement groups are double blinded.

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fasting mimicking diet

Arm Type

Experimental

Arm Description

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

Arm Title

Food supplement

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

4 capsules a day of the placebo for 3 months.

Intervention Type

Other

Intervention Name(s)

Fasting mimicking diet Prolon

Other Intervention Name(s)

FMD, Prolon, L-Nutra

Intervention Description

5-day fasting mimicking diet

Intervention Type

Dietary Supplement

Intervention Name(s)

Food supplement Endocalyx

Other Intervention Name(s)

Endocalyx, Q-prime

Intervention Description

Food supplement

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) in the fasting mimicking diet or food supplement group compared to the placebo

Time Frame

3 months

Title

Percentage change from baseline in urinary heparanase levels in the fasting mimicking diet or food supplement group compared to the placebo

Time Frame

3 months

Title

Percentage change from baseline in urinary MCP-1 levels in the fasting mimicking diet or food supplement group compared to the placebo

Time Frame

3 months

Title

Percentage change from baseline in specific urinary heparan sulfate domains in the fasting mimicking diet or food supplement group compared to the placebo

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ton J. Rabelink, Prof.

Organizational Affiliation

Leiden University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Leiden Universitiy Medical Center (LUMC)

City

Leiden

State/Province

Noord Holland

Country

Netherlands

12. IPD Sharing Statement

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

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