Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20416
Enrollment
96
Registered
2014-07-07
Start date
2014-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes type 2, microalbuminuria

Interventions

During 3 consecutive months, the intervention group receives 200 mg of MOF once daily in the form of a commercially available Food for Special Medical Purposes (Endoclair), whereas the control group r

Sponsors

Erasmus Medical Center, Department of Internal Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • 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.

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

MeasureTime frame
Renal endothelial function will be measured before, during and after the intervention using albumin excretion rate in 24h urine (AER)

Secondary

MeasureTime frame
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).

Contacts

Public ContactKirsten Berk

Erasmus Medical Center

k.berk@erasmusmc.nl+31 (0)10 7033055

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)