Skip to main content
Clinical Trials/NCT04429958
NCT04429958
Completed
Not Applicable

The Belgian Diabetes in Pregnancy Follow-up Study

Universitaire Ziekenhuizen KU Leuven5 sites in 1 country630 target enrollmentJanuary 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
630
Locations
5
Primary Endpoint
BMI in offspring
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 25, 2021
End Date
October 23, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • 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
  • 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

Outcomes

Primary Outcomes

BMI in offspring

Time Frame: 3-7 years after delivery

BMI z score as a continuous variable

A disorder of glucose metabolism in mothers

Time Frame: 3-7 years after delivery

T2DM defined by the 75g OGTT and/or HbA1c, or prediabetes defined by the American Diabetes Association (ADA) criteria

Secondary Outcomes

  • Insulin sensitivity mothers HOMA(3-7 years after delivery)
  • Insulin sensitivity mothers Matsuda(3-7 years after delivery)
  • BMI in mothers(3-7 years after delivery)
  • metabolic syndrome in mothers(3-7 years after delivery)
  • Adiposity offsping skin folds(3-7 years after delivery)
  • Beta-cell function mothers ISSI-2(3-7 years after delivery)
  • Beta-cell function mothers Stumvoll(3-7 years after delivery)
  • Adiposity mothers BIA(3-7 years after delivery)
  • Adiposity mothers skin folds(3-7 years after delivery)
  • overweight offspring(3-7 years after delivery)
  • A disorder of glucose metabolism in offspring(3-7 years after delivery)
  • insulin sensitivity offspring(3-7 years after delivery)
  • Beta-cell function offsping(3-7 years after delivery)
  • Beta-cell function mothers HOMA-B(3-7 years after delivery)
  • metabolic syndrome in offsping(3-7 years after delivery)
  • obesity offspring(3-7 years after delivery)
  • Adiposity offsping BIA(3-7 years after delivery)

Study Sites (5)

Loading locations...

Similar Trials