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

NCT03889236 | Completed

• 1 other identifier: P17.249
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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 specific urinary heparan sulfate domains in the fasting mimicking diet or food supplement group compared to the placebo

  3 months

Study Arms (3)

Fasting mimicking diet

EXPERIMENTAL

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

Other: Fasting mimicking diet Prolon

Food supplement

EXPERIMENTAL

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

Dietary Supplement: Food supplement Endocalyx

Placebo

PLACEBO COMPARATOR

4 capsules a day of the placebo for 3 months.

Dietary Supplement: Placebo

Interventions

Fasting mimicking diet Prolon OTHER

5-day fasting mimicking diet

Also known as: FMD, Prolon, L-Nutra

Fasting mimicking diet

Food supplement Endocalyx DIETARY_SUPPLEMENT

Food supplement

Also known as: Endocalyx, Q-prime

Food supplement

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Dutch Kidney Foundation: collaborator
• Health Holland: collaborator
• Radboud University Medical Center: collaborator

Study Sites (1)

Leiden Universitiy Medical Center (LUMC)

Leiden, North Holland, Netherlands

Location

Related Publications (1)

• van der Velden AIM, IJpelaar DHT, Chandie Shaw PK, Pijl H, Vink H, van der Vlag J, Rabelink TJ, van den Berg BM. Role of dietary interventions on microvascular health in South-Asian Surinamese people with type 2 diabetes in the Netherlands: A randomized controlled trial. Nutr Diabetes. 2024 Apr 10;14(1):17. doi: 10.1038/s41387-024-00275-5.

  PMID: 38600065 DERIVED

MeSH Terms

Conditions

Albuminuria; Glucose Metabolism Disorders; Diabetic Nephropathies; Diabetes Mellitus; Kidney Diseases

Interventions

Gestyl

Condition Hierarchy (Ancestors)

Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Endocrine System Diseases

Study Officials

• Ton J. Rabelink, Prof.

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The placebo and food supplement groups are double blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc.

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

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 26, 2019
• Study Start: May 3, 2018
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

NL (1)