The aim of this randomised, parallel study in patients with DMT2 is to investigate if the added use of skin autofluorescence to the UKPDS risk score will lead to changes in systolic blood pressure and medical treatment (primary measures of effect)…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
-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.
Background summary
The UKPDS study showed that good glycemic control in patients with type 2
diabetes mellitus (DMT2) results in a significant reduction in microvascular
complications. A long-term follow-up extension of the study revealed that early
intervention and good glycemic control early in the disease process, will
result in a long-term reduction in cardiovascular (CV) complications. A recent
study in The Netherlands showed in line with siilar observations in Scotland
and the US that the mortality risk of patients with DMT2 that were relatively
well controlled (HbA1c =7%) and treated (>=30% on statins and RAS inhibitors)
has become comparable to that of the general population (Lutgers 2009).These
results show that a normal life expectancy is achievable in patients with DMT2
when adequately controlled and treated. Good CV risk estimation is essential to
guide such treatment.
The UKPDS risk engine is specifically developed to assess the morbidity and
mortality risk in patients with DMT2 (Stevens 2001). However, in general and
hospital practice this risk engine is still relatively little used , partly
because of the large (10) number of parameters that have to be measured and
filled-in, and because of the known limitations of the risk engine as a
predictor. This emphasizes the importance of additional or alternative risk
factors that can be used to monitor the CV risk and to adjust or intensify
treatment.
Skin auto fluorescence (SAF) was recently introduced as an alternative tool
for cardiovascular risk assessment in diabetic patients (Meerwaldt 2007;
Lutgers 2009). In more than 20% of patients with DMT2 the addition of SAF to
the UKPDS risk score leads to reclassification of *low* or *medium* risk
patients to *high* risk patients, or visa versa. Preliminary results of the
AURORA study in the Netherlands reveal that SAF has a high correlation with the
presence of CV complications. The non-invasive nature of the SAF measurement
makes this a potential valuable and important contribution to the currently
available risk engines, especially for those patients without concurrent CV
complications.
Study objective
The aim of this randomised, parallel study in patients with DMT2 is to
investigate if the added use of skin autofluorescence to the UKPDS risk score
will lead to changes in systolic blood pressure and medical treatment (primary
measures of effect) compared to *standard* CV risk classification using the
UKPDS risk engine,.
Study design
The objective will be tested in a randomised, controlled two-arm
implementation study, in appr. 930 patients with type II diabetes without known
cardiovascular disease, treated by hospital-based physicians in internal
medicine. T2DM patients will be randomised to the first arm in which the
physician receives both the UKPDS RS, and the SAF measurment result, or to the
second arm in which the physician only receives the UKPDS RS result. Changes in
treatment policy between baseline and one year will be assessed. For this
purpose, changes in systolic blood pressure and in medical treatment between
baseline and 1 year follow-up (primary end points), and the changes in lipids
and glycemic contro/HbA1c (secondary end points) will be assessed.
Within the SAF+UKPFDS arm, measures like net reclassification will also be
calculated.in subgroups with concordant and discordant results of SAF and UKPDS
RS.
As stated above a concordance/discordance analysis within the participants
randomised to the arm with provision of both UKPDS RE and SAF resutlts will be
performed by a form of reclassification analysis, classifying four groups:
oGroup 1 (*high/low group*), where risk classification at baseline using the
UKPDS risk engine is different from risk classification using an AGE Reader:
i.e. patients classified as UKPDS risk score > 10% but autofluorescence <
median.
oGroup 2 (*low/high group*), where risk classification at baseline using the
UKPDS risk engine is different from risk classification using an AGE Reader:
i.e. patients classified as UKPDS risk score < 10% but autofluorescence >
median.
oGroup 3 (*high/high group*), where risk classification at baseline using the
UKPDS risk engine is similar to risk classification using an AGE Reader: i.e.
patients classified as UKPDS risk score > 10% and autofluorescence > median.
oGroup 4 (*low/low group*), where risk classification at baseline using the
UKPDS risk engine is similar to risk classification using an AGE Reader: i.e.
patients classified as UKPDS risk score < 10% and autofluorescence < median.
Study burden and risks
All measurements are also performed in regular clinical practice: the project
involves a registry of performed laboratory follow-up assessments and
treatment changes. It also involves the performance of SAF measurements at
baseline and after one year. No extra visits, blood samples or physical
examinations.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
type 2 diabetes mellitus
Exclusion criteria
factors which may affect UKPDS risk engine score or autofluorescence measurement, such as South Asian descent, diffuse skin dsease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33505.042.10 |