se of monomeric and oligomeric flavanols in the dietary management of patients with type 2 diabetes and microalbuminuria
- Conditions
- Diabetes type 2, microalbuminuria
- Registration Number
- NL-OMON20416
- Lead Sponsor
- Erasmus Medical Center, Department of Internal Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 96
• T2D
• Age 40-85 years
• Microalbuminuria in the previous 6 months (as microalbuminuria can change during time, results shouldn’t be older than 6 months), defined as:
- 30-300 mg albumin in a 24-hour urine sample
- or 3.5-35 mg albumin/mmol creatinine in females and 2.5-25 mg albumin/mmol creatinine in males in a urine portion.
This definition is derived from the Dutch national guidelines.
• Other types of diabetes mellitus as derived from the medical records
• Prior (less than 4 weeks before participating) or current use of any specific dietary supplementary products providing daily amounts of MOF of 25 mg/day or higher
• Anticoagulation medication
• Major health conditions: organ transplantation, untreated cancer, current chemotherapy or radiotherapy, acute or chronic organ failure
• Microalbuminuria due to other conditions than T2D
• Pregnancy or lactation during the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Renal endothelial function will be measured before, during and after the intervention using albumin excretion rate in 24h urine (AER)
- Secondary Outcome Measures
Name Time Method Established plasma biomarkers for renal endothelial function, namely asymmetric dimethylarginine (ADMA), vascular cell adhesion molecule 1 (VCAM-1), interleukin 6 (IL-6), von Willebrand Factor (vWF) and intercellular cell adhesion molecule 1 (ICAM-1).