Advanced Glycation Endproducts (AGEs) in pregnancies complicated by diabetes mellitus and the accumulation of AGEs in the neonates

Completed

• Conditions: diabetes; Dysglycemia; 10012653; 10010273

• Registration Number: NL-OMON34029
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 550

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.
Controls will be healthy pregnant and non-pregnant women and non-pregnant women with DM1 or DM2 in the age range of 18-40 years and all children of these above mentioned women who deliver in the UMCG. Thereby, we will include a group of control neonates born after an uncomplicated pregnancy.

Exclusion Criteria

Pregnant women with DM1 or DM2:
- HbA1c >8%
- Renal failure (serum creatinine >120 µmol/L)
- Fitzpatrick skin type VI (negroid skin colour), or skin reflectance <6% or local skin abnormalities of the volar side of the lower arms
- Recent (< 3 months) serious (requiring hospital admission) infection or cardiovascular event;Pregnant women with GDM:
- HbA1c >7% after 20-24 weeks of gestation
- Treatment of GDM with diet only
- Renal failure (serum creatinine >120 µmol/L)
- Fitzpatrick skin type VI (negroid skin colour), or skin reflectance <6% or local skin abnormalities of the volar side of the lower arms
- Recent (< 3 months) serious (requiring hospital admission) infection or cardiovascular event;Healthy (non-)pregnant women:
- Known active disease
- Fitzpatrick skin type VI (negroid skin colour), or skin reflectance <6% or local skin abnormalities of the volar side of the lower arms
- Recent (< 3 months) serious (requiring hospital admission) infection or cardiovascular event;Non-pregnant women with DM1 or DM2:
- HbA1c >8%
- Pregnancy
- Renal failure (serum creatinine >120 µmol/L)
- Fitzpatrick skin type VI (negroid skin colour), or skin reflectance <6% or local skin abnormalities of the volar side of the lower arms
- Recent (< 3 months) serious (requiring hospital admission) infection or cardiovascular event;Neonates (control group):
- When the mother is excluded
- Congenital malformations
- Gestational age < 37 weeks
- Birth weight < P25 or > P75
- Fitzpatrick skin type VI (negroid skin colour)
- Measurement > 24 hours postpartum

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified