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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38296
Enrollment
800
Registered
2012-03-01
Start date
2012-06-19
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Type 2 diabetes

Interventions

None listed

Sponsors

Univ. Prof. Dr. Gert Mayer, Universitätsklinik für Innere Medizin IV (Nephrologie und Hypertensiologie)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 1. Patients with malignancy on current active treatment

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)