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

Leiden University Medical Center (LUMC)

Status: Completed

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

Treatments: Other: Fasting mimicking diet Prolon; Dietary Supplement: Placebo; Dietary Supplement: Food supplement Endocalyx

Study type: Interventional

Funder types: Other

Identifiers

NCT03889236

P17.249

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 3 patient groups, including a placebo group

Fasting mimicking diet

Experimental group

Description:

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

Treatment:

Other: Fasting mimicking diet Prolon

Food supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Food supplement Endocalyx

Placebo

Placebo Comparator group

Description:

4 capsules a day of the placebo for 3 months.

Treatment:

Dietary Supplement: Placebo