To evaluate whether a higher SAF level is related to a higher incidence of macrosomiaTo evaluate if a higher SAF level is related to a higher incidence of other maternal, fetal or neonatal complications To evaluate is SAF level is related to a…
ID
Source
Brief title
Condition
- Diabetic complications
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
SAF level
Secondary outcome
complications
necessity of insulin
type 2 diabetes after diagnosis
glucose values at OGTT
Background summary
AGEs can be measured by skin autofluorescence (SAF) and are known to accumulate
in diabetes. Moreover the level of SAF predicts macro- and microvascular
complications. Since SAF is an indicator of the degree of derangement of the
glucose homeostasis, it is well possible that SAF level is related to
complications in pregnant patients with diabetes.
Study objective
To evaluate whether a higher SAF level is related to a higher incidence of
macrosomia
To evaluate if a higher SAF level is related to a higher incidence of other
maternal, fetal or neonatal complications
To evaluate is SAF level is related to a higher necessity of insulin treatment
during pregnancy in GDM patients only
To evaluate if SAF level is related to a higher development of type 2 diabetes
during the first year after delivery in GDM patients only
Study design
Observational
Study burden and risks
The SAF measurement is a non-invasive procedure, without any risks or
side-effects. Measurements coincide with usual outpatient visits. Only in GDM
an extra visit is needed 1 year after delivery to measure glucose and SAF
again.
The current individual patient does not benefit from participation but with
positive results, SAF measurement will contribute to improvement in the care
for pregnancy complicated by diabetes.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
-Pregnant patients with diabetes (GDM or pre-existent diabetes mellitus) or patients with one abnormal value at OGTT
-Written informed consent
-Knowledge of Dutch
Exclusion criteria
-renal failure (GFR < 30 ml/min)
-Negroid skin type
-skin reflectance < 6% (the AGE-reader will automatically give an alarm when reflection is too low for the measurement to be reliable, these patients will be excluded)
-pre-eclampsia at inclusion
-Recent (< 6 months) serious infection or infarction or hospital admission/ or clinical condition judged by the investigator as interfering with skin autofluorescence measurement
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 | NL30990.041.09 |