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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-03

Study Completion Date

2020-09-09

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The placebo and food supplement groups are double blinded.

Study Groups

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Fasting mimicking diet

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

Group Type EXPERIMENTAL

Fasting mimicking diet Prolon

Intervention Type OTHER

5-day fasting mimicking diet

Food supplement

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

Group Type EXPERIMENTAL

Food supplement Endocalyx

Intervention Type DIETARY_SUPPLEMENT

Food supplement

Placebo

4 capsules a day of the placebo for 3 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Fasting mimicking diet Prolon

5-day fasting mimicking diet

Intervention Type OTHER

Food supplement Endocalyx

Food supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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FMD Prolon L-Nutra Endocalyx Q-prime

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No