To investigate whether SAF is elevated in GDM versus non-diabetic pregnancy To investigate whther SAF levels change during the course of normal and GDM pregnancy To investigate if SAF is related to other parameters of hyperglycemia (HbA1c, self…
ID
Source
Brief title
Condition
- Diabetic complications
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
SAF level of GDM women compared to non-diabetic pregnant women
Secondary outcome
laboratory assessments: glucose, HbA1c, fructosamine
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 will be elevated in
gestational diabetes. It is unkonwn whether SAF indeed accumulate in
gestational diabetes.
Study objective
To investigate whether SAF is elevated in GDM versus non-diabetic pregnancy
To investigate whther SAF levels change during the course of normal and GDM
pregnancy
To investigate if SAF is related to other parameters of hyperglycemia (HbA1c,
self monitored blood glucose)
Study design
observational
Study burden and risks
The SAF measurement is a non-invasive procedure, without any risks or
side-effects.
The current individual patient does not benefit from participation but with
positive results, SAF measurement will contribute to improvement in the care
for patients with GDM.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
-Pregnant patients (non-diabetic or GDM)
-Written informed consent
-Knowledge of Dutch
- Planned for a screening challenge test (50 gr)
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
- GDM not confirmed by positive OGTT
- Control (non-diabetic) not confirmed by negative challenge test
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 | NL29806.041.09 |