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

Not Applicable

Completed

• Conditions: Diabetic Nephropathy Type 2; Albuminuria; Glucose Metabolism Disorders; Microalbuminuria; Diabetic Nephropathies; Kidney Diseases; Type2 Diabetes Mellitus; South Asian; Diabetic Complications Renal; Diabetes Mellitus
• Interventions: Other: Fasting mimicking diet Prolon; Dietary Supplement: Placebo; Dietary Supplement: Food supplement Endocalyx

• Registration Number: NCT03889236
• Lead Sponsor: Leiden University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-03
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-26
• Primary Completion: 2020-09-09
• Study Completion: 2020-09-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fasting mimicking diet	Fasting mimicking diet Prolon	5-day Fasting mimicking diet Prolon. In total 3 cycles of the FMD in three months.
Placebo	Placebo	4 capsules a day of the placebo for 3 months.
Food supplement	Food supplement Endocalyx	4 capsules a day of the food supplement Endocalyx for 3 months.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Leiden Universitiy Medical Center (LUMC); 🇳🇱 Leiden, Noord Holland, Netherlands