SAF in diabetic pregnancies.
Recruiting
- Conditions
- Diabetes MellitusPregnancyAdvanced Glycation Endproducts
- Registration Number
- NL-OMON23319
- Lead Sponsor
- niversity Medical Centre Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
Pregnant women with known DM1, DM2, GDM in the age range of 18-40 years. Pregnant women with DM1, DM2 and GDM can only be included when the glucose levels are established in the following range:
HbA1c <8%, if possible measured during last menstrual cycle, last outpatient visit before pregnancy if within period < 4 months or at first visit after positive pregnancy test.
Exclusion Criteria
Pregnant women with DM1 or DM2:
1. HbA1c >8%;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the accumulation of AGEs in the skin and serum of pregnant women with DM1, DM2 or GDM, in comparison to healthy pregnant women and non-pregnant women with DM1 or DM2. The accumulation of soft tissue AGEs will be measured by the skin autofluorescence reader and sAGES will be measured in maternal serum.
- Secondary Outcome Measures
Name Time Method Secondary Objective(s): <br /><br>1. To asses the inflammatory response by measurement of inflammation markers in maternal serum in pregnant women with DM1, DM2 or GDM. This response will be measured twice, namely firstly in the third trimester and secondly 6-12 weeks after delivery;<br /><br>2. To asses the relation between skin autofluorescence (SAF) and presence or development of impaired glucose tolerance (IGT) or DM after pregnancy, as assessed by OGTT 6-12 weeks after delivery. Furthermore, the relation between SAF and maternal, fetal and neonatal complications will be assessed.