AVENIR project:: AGE in Vascular risk Estimation and Normalisation by Intensified Reduction in diabetes type 2.
Recruiting
- Conditions
- diabetes mellitus type 2
- Registration Number
- NL-OMON28161
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 800
Inclusion Criteria
1. Type 2 diabetes mellitus, based on usual WHO (2005) or ADA (2010) criteria;
2. Age 25-65 years;
Exclusion Criteria
1. Other conditions which may affect the interpretation of the UKPDS risk engine or skin autofluorescence measurements;
2. Persons from South Asian descent (UKPDS RE not valid in this group);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in primary (one-year change in medication and in systolic blood pressure) will be compared between both arms.
- Secondary Outcome Measures
Name Time Method 1. Changes overall in HbA1c, LDL-cholesterol, skin autofluorescence (AGE reader), UKPDS risk score between baseline and one year;<br /><br>2. Changes in UKPDS score and SAF from baseline to 1 year between the group in whom CV risk estimated with SAF and that estimated with the UKPDS risk engine is (higher or lower class) than that estimated with the UKPDS risk score, compared to the group in whom both rsisk estimated are concordant;<br /><br>3. Differences between the concordant and discordant groups in target treatment values of blood pressure and lipids used by the treating physician. This will be assessed using a questionnaire.