The aim of the study is to assess the possible additive value of the AGE reader measurement in a group of hospital-controlled (high-risk) persons with type 2 DM.
ID
Source
Brief title
Condition
- Diabetic complications
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Exisiting complications macrovascular according to ICD guidelines
Existing microvascular complications, according to standard classifications
degree: retinopathy, nephropathy, (neuropathy)
Optionally: inventarisation development complications above during follow-up
Secondary outcome
ïnventarisatie satisfaction of diabetes specialist about AGE reader as
contribution to future decision making in type 2 DM
Background summary
Current cardiovascular risk prediction models are no more than moderately
effective and precise. This also holds for the only model available for type 2
diabetes, the socalled UKPDS risk engine model. Nevertheless, such models are
used for importnat, lifelong treatment decisions, guideline even advise to use
them. There is a clear need for additional tools to make predictions more
accurate.
The AGE reader is a noninvasive device to assess the skin level of advanced
glycation endproducts which have an important pathogenetic role in the
development of diabetic complications. The AGE reader has been shown to be a
strong and independent predictor of CVD in well-controlles type diabetes
patients with short diabetes duration (Zwolle study). It provides predictive
information in addition to conventional risk factors and scores.
The aim of the study is to assess the possible additive value of the AGE reader
measurement in assessing the relation with existing (and optionally future)
macrovascular and microvascular complications in a group of hospital-controlled
(high-risk) persons with type 2 DM.
Study objective
The aim of the study is to assess the possible additive value of the AGE reader
measurement in a group of hospital-controlled (high-risk) persons with type 2
DM.
Study design
observational study with optional follow-up period
Study burden and risks
no burden, no risk
Postbus 30001
9700 RB Groningen
Nederland
Postbus 30001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
type 2 diabetes mellitus
Exclusion criteria
hypothyroidism, use of medication inducing secondary hypetension, icterus, moderate-severe anemia (Hb < 6 mol/l), diseases affecting survival at short term, alcohol- or drugabuse, (recent, < 30 days) particpation other study, no consent form
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 | NL13883.042.06 |