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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03889236
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborators:
Dutch Kidney Foundation
Health Holland
Radboud University
Information provided by (Responsible Party):
AnoukvanderVelden, 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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Type 2 Albuminuria Type2 Diabetes Mellitus Glucose Metabolism Disorders Microalbuminuria Diabetic Nephropathies Diabetic Complications Renal Diabetes Mellitus Kidney Diseases South Asian Other: Fasting mimicking diet Prolon Dietary Supplement: Food supplement Endocalyx Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomized into the diet group, food supplement group or placebo group. The placebo and foodsupplement groups are double blinded.
Masking: Double (Participant, Investigator)
Masking Description: The placebo and food supplement groups are double blinded.
Primary Purpose: Treatment
Official Title: The Effect of Dietary Interventions on Endothelial Glycocalyx Dimensions and Barrier Function in South Asian Patients With Diabetic Nephropathy.
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fasting mimicking diet
5-day Fasting mimicking diet Prolon. In total 3 cycles of the FMD in three months.
Other: Fasting mimicking diet Prolon
5-day fasting mimicking diet
Other Names:
  • FMD
  • Prolon
  • L-Nutra

Experimental: Food supplement
4 capsules a day of the food supplement Endocalyx for 3 months.
Dietary Supplement: Food supplement Endocalyx
Food supplement
Other Names:
  • Endocalyx
  • Q-prime

Placebo Comparator: Placebo
4 capsules a day of the placebo for 3 months.
Dietary Supplement: Placebo
Placebo




Primary Outcome Measures :
  1. Percentage change from baseline in the Microvascular Health Index in the fasting mimicking diet or food supplement group compared to the placebo group [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) in the fasting mimicking diet or food supplement group compared to the placebo [ Time Frame: 3 months ]
  2. Percentage change from baseline in urinary heparanase levels in the fasting mimicking diet or food supplement group compared to the placebo [ Time Frame: 3 months ]
  3. Percentage change from baseline in urinary MCP-1 levels in the fasting mimicking diet or food supplement group compared to the placebo [ Time Frame: 3 months ]
  4. Percentage change from baseline in specific urinary heparan sulfate domains in the fasting mimicking diet or food supplement group compared to the placebo [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889236


Contacts
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Contact: Anouk I.M. van der Velden, Msc. +31 (0)71- 5296907 A.I.M.van_der_Velden@lumc.nl
Contact: Daphne H.T. Ijpelaar, Dr. D.H.T.Ijpelaar@lumc.nl

Locations
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Netherlands
Leiden Universitiy Medical Center (LUMC) Recruiting
Leiden, Noord Holland, Netherlands
Contact: Anouk I.M. van der Velden, Msc    +31 (0)71- 5296907    a.i.m.van_der_velden@lumc.nl   
Sponsors and Collaborators
Leiden University Medical Center
Dutch Kidney Foundation
Health Holland
Radboud University
Investigators
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Principal Investigator: Ton J. Rabelink, Prof. Leiden University Medical Center
  Study Documents (Full-Text)

Documents provided by AnoukvanderVelden, Leiden University Medical Center:
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Responsible Party: AnoukvanderVelden, Msc., Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT03889236    
Other Study ID Numbers: P17.249
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Albuminuria
Diabetes Mellitus
Metabolic Diseases
Glucose Metabolism Disorders
Diabetes Complications
Endocrine System Diseases
Urologic Diseases
Proteinuria
Urination Disorders
Urological Manifestations
Signs and Symptoms