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

Diabetes Mellitus Clinical Trial

— Glycotreat  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889236
• Other study ID #: P17.249
• Status: Completed
• Phase: N/A
• Start date: May 3, 2018
• Est. completion date: September 9, 2020

Study information

• Verified date: February 2021
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 9, 2020
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Fasting mimicking diet Prolon
5-day fasting mimicking diet

Dietary Supplement:
• Food supplement Endocalyx
Food supplement
• Placebo
Placebo

Locations

Country	Name	City	State
Netherlands	Leiden Universitiy Medical Center (LUMC)	Leiden	Noord Holland

Sponsors (4)

Lead Sponsor	Collaborator
Leiden University Medical Center	Dutch Kidney Foundation, Health Holland, Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Percentage change from baseline in urinary heparanase levels in the fasting mimicking diet or food supplement group compared to the placebo		3 months
Secondary	Percentage change from baseline in urinary MCP-1 levels in the fasting mimicking diet or food supplement group compared to the placebo		3 months
Secondary	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