The role of immunology in diabetes mellitus and pregnancy

Completed

• Conditions: diabetes; Dysglycemia; 10018424; 10003816; 10029903

• Registration Number: NL-OMON36546
• 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: 120

Inclusion Criteria

Group 1: Pregnant women with DM1 >18 en <40 yrs
Group 2: Pregnant women with DM2 >18 en <40 yrs
Group 3: Healthy pregnant women >18 en <40 yrs
Group 4: Non-pregnant women with DM1 >18 and <40 yrs
Group 5: Non-pregnant women with DM2 >18 and <40 yrs
Group 6: Healthy non-pregnant women >18 en <40 yrs

Exclusion Criteria

Group 1,2:
- HbA1c >7,5% after 30 weeks of gestation
- Renal failure (serum creatinine >120 µmol/L)
- Active treatment for auto-immune disease, except substitution therapy for primary hypothyroidism with TBII <1. ;Group 3:
- Gestational diabetes mellitus
- Intrauterine growth restriction (defined as foetal weight <10th percentile for gestational age).
- >2 times of miscarriage (defined as loss of pregnancy during the first 23 weeks of gestation)
- All other maternal and foetal complications
- Known active disease;Group 4, 5:
- HbA1c >7,5%
- Renal failure (serum creatinine >120 µmol/L)
- Active treatment for auto-immune disease, except substitution therapy for primary hypothyroidism with TBII <1. ;Group 6:
- Known active disease, except substitution therapy for primary hypothyroidism with TBII <1.

Study & Design

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