Clinical trial NCT04429958: The Belgian Diabetes in Pregnancy Follow-up Study
Official title: The Belgian Diabetes in Pregnancy Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Type2 Diabetes
Obesity
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
name: Onze Lieve Vrouw Hospital
name: Imelda Bonheiden
First posted: 2020-06-12
Enrollment: 630
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We plan to recruit 375 women-offspring pairs with the five largest centers who participated in the initial BEDIP study. Women and offspring will be recruited according to 3 different subgroups based on the antenatal result of the GCT and OGTT in the index pregnancy (a sample of 125 in each group): GDM group; normal glucose tolerance (NGT) on the OGTT with an abnormal preceding GCT (abnormal GCT NGT group); NGT on the OGTT with a normal preceding GCT (normal GCT NGT group). Abnormal GCT is defined as glucose≥130mg/dl, in line with our previous research.

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.


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:

* 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

Primary outcomes:
measure: A disorder of glucose metabolism in mothers
timeFrame: 3-7 years after delivery
measure: BMI in offspring
timeFrame: 3-7 years after delivery
Secondary outcomes:
measure: BMI in mothers
timeFrame: 3-7 years after delivery
measure: metabolic syndrome in mothers
timeFrame: 3-7 years after delivery
measure: Insulin sensitivity mothers Matsuda
timeFrame: 3-7 years after delivery
measure: Insulin sensitivity mothers HOMA
timeFrame: 3-7 years after delivery
measure: Beta-cell function mothers HOMA-B
timeFrame: 3-7 years after delivery
measure: Beta-cell function mothers ISSI-2
timeFrame: 3-7 years after delivery
measure: Beta-cell function mothers Stumvoll
timeFrame: 3-7 years after delivery
measure: Adiposity mothers BIA
timeFrame: 3-7 years after delivery
measure: Adiposity mothers skin folds
timeFrame: 3-7 years after delivery
measure: overweight offspring
timeFrame: 3-7 years after delivery
measure: obesity offspring
timeFrame: 3-7 years after delivery
measure: A disorder of glucose metabolism in offspring
timeFrame: 3-7 years after delivery
measure: metabolic syndrome in offsping
timeFrame: 3-7 years after delivery
measure: insulin sensitivity offspring
timeFrame: 3-7 years after delivery
measure: Beta-cell function offsping
timeFrame: 3-7 years after delivery
measure: Adiposity offsping BIA
timeFrame: 3-7 years after delivery
measure: Adiposity offsping skin folds
timeFrame: 3-7 years after delivery
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV-Alast
city: Antwerp
country: Belgium
facility: UZA
city: Asse
country: Belgium
facility: OLV-Asse
city: Bonheiden
country: Belgium
facility: Imelda Bonheiden
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Katrien Benhalima
role: PRINCIPAL_INVESTIGATOR
References: