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| Name | Class |
|---|---|
| Dutch Kidney Foundation | OTHER |
| Health Holland | OTHER |
| Radboud University Medical Center | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting mimicking diet | Experimental | 5-day Fasting mimicking diet Prolon. In total 3 cycles of the FMD in three months. |
|
| Food supplement | Experimental | 4 capsules a day of the food supplement Endocalyx for 3 months. |
|
| Placebo | Placebo Comparator | 4 capsules a day of the placebo for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting mimicking diet Prolon | Other | 5-day fasting mimicking diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
4.3 Exclusion
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ton J. Rabelink, Prof. | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden Universitiy Medical Center (LUMC) | Leiden | North Holland | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38600065 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 27, 2018 |
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Patients are randomized into the diet group, food supplement group or placebo group. The placebo and foodsupplement groups are double blinded.
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The placebo and food supplement groups are double blinded.
| Food supplement Endocalyx | Dietary Supplement | Food supplement |
|
|
| Placebo | Dietary Supplement | 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 |
| Mar 7, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000419 | Albuminuria |
| D044882 | Glucose Metabolism Disorders |
| D003928 | Diabetic Nephropathies |
| D003920 | Diabetes Mellitus |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C011261 | Gestyl |
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