The Belgian Diabetes in Pregnancy Follow-up Study (BEDIP-FUS)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Gestational Diabetes; Type2 Diabetes; Obesity

Treatments: Other: GDM

Study type: Observational

Funder types: Other

Identifiers

NCT04429958

S64070

Details and patient eligibility

About

Gestational diabetes (GDM) is a form of diabetes that develops during pregnancy. GDM is associated with increased risks for pregnancy complications such as macrosomia s and preterm delivery. Women with a history of GDM have a high risk to develop a type 2 diabetes (T2DM) within the next ten years after delivery. The children are also at increased risk of developing obesity and T2DM later in life. Studies are needed to find more accurate predictors for the metabolic risk later in life. This will help to individualize the follow-up and to develop tailored prevention strategies in women and offspring with a history of GDM. In this research project we will therefore investigate how the long-term metabolic risk can more accurately be predicted in a follow-up cohort of the 'Belgian Diabetes in Pregnancy study' (BEDIP-N). We will study the relationship between maternal weight, degree of body fat and degree of hyperglycaemia in pregnancy on the long-term metabolic risk of 375 women and offspring pairs 3-7 years after the delivery across different gestational glucose tolerance groups based on the 2013 WHO criteria in pregnancy. In addition, we will study whether a promising new biomarker, glycated CD59, is a good predictor for the long-term metabolic risk.

Enrollment: 630 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mothers who participated in the completed BEDIP-N study and received both the GCT as the OGTT during pregnancy
• Offspring born at the time of participation in the BEDIP-N study

Exclusion criteria

• Mothers:

  • Current pregnancy
  • Treatment that influences glycaemic status such as high dose corticoids.
  • History of bariatric surgery
  • gastro-intestinal surgery changing the absorption of glucose (Billroth II)
  • A normal study visit will not be possible (incompliance, psychiatric problems...)
  • Diagnosed with type 1 diabetes or the presence of auto-immune antibodies for type 1 diabetes

Offspring:

• Treatment that influences glycaemic status such as high dose corticoids.
• A normal study visit will not be possible (incompliance, psychiatric problems...)
• Diagnosed with type 1 diabetes or the presence of auto-immune antibodies for type 1 diabetes

Trial design

630 participants in 3 patient groups

GDM

Description:

125 mothers with a history of GDM in pregnancy at the time of the BEDIP study and their offspring born during the BEDIP study

Treatment:

Other: GDM

abnormal GCT group

Description:

125 mothers with an abnormal glucose challange test (GCT of 130mg/dl or more) in pregnancy at the time of the BEDIP study and their offspring born during the BEDIP study

normal group

Description:

125 mothers with both a normal GCT and OGT in pregnancy at the time of the BEDIP study and their offspring born during the BEDIP study