se of monomeric and oligomeric flavanols in the dietary management of patients with type 2 diabetes and microalbuminuria

Completed

• Conditions: kidney protein leakage in diabetes; Microalbuminuria in diabetes type 2; 10012653

• Registration Number: NL-OMON46959
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 114

Inclusion Criteria

• Diagnosed diabetes mellitus type 2
• Age 40-85
• Micro albuminuria (>=20 *g albumin/min in 24h urine or albumin/creatinine ratio of >=2,5 (male) or >=3,5 (female) in urine portion) measured in the last 6 months

Exclusion Criteria

• Prior or current use of the Investigational Product and/or similar products (dietary supplements and/or FSMP*s) (to avoid de-blinding)
• Use of anticoagulants
• History of any organ transplantation
• Albuminuria due to other causes, such as systemic lupus erythematodes (SLE) or sarcoidosis
• Pregnancy or lactation during the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in microalbuminuria between baseline and 3 months, measured as Albumin<br /><br>Excretion Rate (AER) in 24h urine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Biomarkers for endothelial function and progression of nephropathie:<br /><br>- asymmetric dimethylarginine (ADMA)<br /><br>- vascular cell adhesion molecule 1 (VCAM-1)<br /><br>- intercellular cell adhesion molecule 1 (ICAM-1)<br /><br>- interleukin 6 (IL-6)<br /><br>- von Willebrand Factor (vWF)</p><br>