AVENIR project:: AGE in Vascular risk Estimation and Normalisation by Intensified Reduction in diabetes type 2

AVENIR project:: AGE in Vascular risk Estimation and Normalisation by Intensified Reduction in diabetes type 2 - AVENIR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34555

Enrollment

930

Registered

2011-03-01

Start date

2011-05-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

diabetic cardiovascular complications

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: type 2 diabetes mellitus

Exclusion criteria

Exclusion criteria: factors which may affect UKPDS risk engine score or autofluorescence measurement, such as South Asian descent, diffuse skin dsease

Design outcomes

Primary

Measure	Time frame
The difference in reduction from baseline to the end of the study (one year) in systolic blood pressure and in blood pressure, lipid lowering and anitdiabetic medication between the two arms. Systolic blood pressure has been used for power analysis.	—

Secondary

Measure	Time frame
-changes over 1 year in HbA1c, LDL-cholesterol; idem for autofluorescence (AGE reader), UKPDS risk score between baseline and one year. - changes in UKPDS score and SAF from baseline to 1 year, compared between the subgroups within the SAF+UKPDS arm, in which CV risk estimated with SAF and that estimated with the UKPDS risk engine is in a higher or lower risk class than that estimated with the UKPDS risk score, compared to the group in whom both risk class estimates are concordant. -differences between the abovementioned concordant and discordant subgroups in target treatment values of blood pressure and lipids used by the treating physician. This will be assessed using a questionnaire -questions about the effect of the availability of skin autofluorescence and of the UKPDS RE values on treatment as perceived by the treating physician using a questionnaire In addition the reduction from baseline to one year in systolic blood pressure, and in blood pressure, lipid lowering and anitdiabetic medication, and in lipid and HbA1c levels will also be compared in an aselected (only age decade and sex disitribution matched) sample of T2DM patients from the same center in whom neither SAF nor UKPDS score has been measured or provided to the treating physician. To avoid potential study participation bias, we propose not to ask for patient consent. The selection wil be made once the general characterisitcs (age and sex distribution) of the randomised patiens are known, so after the 1st inclusion year. Otherwise, similar end point data will be collected as in the randomised participants, except those of the UKPDS score and SAF measurements. The (local) investigators will select these patients from their hospital database, and will regsiter the data in an anonimised manner.	—

Measure

Time frame

-changes over 1 year in HbA1c, LDL-cholesterol; idem for autofluorescence (AGE reader), UKPDS risk score between baseline and one year. - changes in UKPDS score and SAF from baseline to 1 year, compared between the subgroups within the SAF+UKPDS arm, in which CV risk estimated with SAF and that estimated with the UKPDS risk engine is in a higher or lower risk class than that estimated with the UKPDS risk score, compared to the group in whom both risk class estimates are concordant. -differences between the abovementioned concordant and discordant subgroups in target treatment values of blood pressure and lipids used by the treating physician. This will be assessed using a questionnaire -questions about the effect of the availability of skin autofluorescence and of the UKPDS RE values on treatment as perceived by the treating physician using a questionnaire In addition the reduction from baseline to one year in systolic blood pressure, and in blood pressure, lipid lowering and anitdiabetic medication, and in lipid and HbA1c levels will also be compared in an aselected (only age decade and sex disitribution matched) sample of T2DM patients from the same center in whom neither SAF nor UKPDS score has been measured or provided to the treating physician. To avoid potential study participation bias, we propose not to ask for patient consent. The selection wil be made once the general characterisitcs (age and sex distribution) of the randomised patiens are known, so after the 1st inclusion year. Otherwise, similar end point data will be collected as in the randomised participants, except those of the UKPDS score and SAF measurements. The (local) investigators will select these patients from their hospital database, and will regsiter the data in an anonimised manner.

—

Countries

Netherlands

Outcome results