The aim of this study is to investigate if changes in vascular compliance in children with type 1 diabetes are related to endothelial markers and to changes in skin AGE and to investigate whether patients at risk to develop cardiovascular disease…
ID
Source
Brief title
Condition
- Diabetic complications
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
AGE-measurement, vascular compliance and endothelial markers in blood.
Secondary outcome
Duration of diabetes, HbA1c, BMI, body composition, smoking, lipid
concentrations, microalbuminuria, retinopathy, insulin dosage per kg body
weight, family history of cardiovascular disease, hypertension,
hypercholesterolemie or diabetes.
Background summary
Type 1 diabetes is associated with microvascular complications (retinopathy,
nephropathy, neuropathy) and macrovascular complications (cardiovascular
disease). It is important to identify additional risk factors for
cardiovascular disease and to identify atherosclerosis early, to carry out
necessary interventions. Skin advanced glycation end products (AGE) measured by
autofluoresence have been described as predictor of complications independent
of HbA1c in adults with type 1 and type 2 diabetes. In children no association
between skin AGE and complications has been made sofar. Early signs of
atherosclerosis can be discovered by investigating vascular compliance.
Endothelial markers can also be used as early markers for atherosclerosis.
Study objective
The aim of this study is to investigate if changes in vascular compliance in
children with type 1 diabetes are related to endothelial markers and to changes
in skin AGE and to investigate whether patients at risk to develop
cardiovascular disease can be identified early in life in order to be able to
take preventive measures
Study design
In a cross sectional study design, skin AGE will be measured in type 1 diabetic
patients in all age groups. Vascular compliance will be measured once in
patients of eight years and older, scheduled during regular visits at the
paediatric and adolescent diabetes clinic. Blood samples for endothelial
markers will drawn combined with their yearly laboratory check-up. Controls for
skin AGE and vascular compliance measurements will be age matched friends of
the patients.
Study burden and risks
Measurements will be performed at a regular outpatient visit and blood samples
will be taken only from the patients at their regular yearly laboratory check.
AGE measurement takes only a few seconds. For the measurement of vascular
compliance using applanation tonometry, subjects must lay still for about 20
minutes. There are no risks for the patients or controls. Benefit for the
patients could be that patients with a higher risk for atherosclerosis are
identified, so that in the future, interventions decreasing the atherosclerotic
risk can be applied.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
type 1 diabetes
Exclusion criteria
Other forms of diabetes (type 2, MODY, CFRD etc.)
Local skin disease of the lower arm obviating skin autofluorescence measurement
Very dark skin influencing skin autofluorescence measurement (reflectance <8%; Fitzpatrick skin type V-VI)
Arm too small to cover the window of the AGE reader
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 | NL47341.042.14 |