Multinational, prospective cohort-study in patients with type 2 diabetes for validation of biomarkers

Completed

• Conditions: Type 2 diabetes; 10012653; 10029149

• Registration Number: NL-OMON38296
• Lead Sponsor: niv. Prof. Dr. Gert Mayer, Universitätsklinik für Innere Medizin IV (Nephrologie und Hypertensiologie)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 800

Inclusion Criteria

1. Patient age > 18 years
2. Incident or prevalent patients with type II diabetes mellitus
3. Patients who are willing to sign informed consent to provide blood and urine samples

Exclusion Criteria

1. Patients with malignancy on current active treatment

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Renal outcomes are defined as<br /><br>* Progression from normoalbuminuria to microalbuminuria (including > 30%<br /><br>increase in albuminuria from baseline)<br /><br>* Progression from microalbuminuria to macroalbuminuria (including > 30%<br /><br>increase in albuminuria from baseline)<br /><br>* Progression to doubling of serum creatinine, end stage renal disease (ESRD)<br /><br>or death.<br /><br>Cut-off values indicating normoalbuminuria, microalbuminuria, and<br /><br>macroalbuminuria are defined as:<br /><br>24 hour timed<br /><br>overnight first morning sample<br /><br>mg / 24 hour<br /><br>ug / min mg / g creatinin<br /><br><br /><br>Normoalbuminuria < 30 <<br /><br>20 < 30<br /><br>Microalbuminuria 30 - 300 20<br /><br>- 200 30 - 300<br /><br>Macroalbuminuria > 300<br /><br>> 200 > 300</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cardiovascular outcomes are defined as<br /><br>• cardiovascular death<br /><br>• non fatal myocardial infarction or non fatal stroke<br /><br>• hospitalization because of heart failure<br /><br>The diagnosis of cardiovascular events is made based on the treating<br /><br>physician*s judgement and checked by the adjudication endpoint committee. The<br /><br>adjudication endpoint committee consists of members located in each<br /><br>participating country. The national coordinator is responsible for annual<br /><br>random check of the quality of data entry. He/she is also responsible for<br /><br>correct patient follow up in case the treating physician changes.</p><br>