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The Belgian Diabetes in Pregnancy Follow-up Study

The Belgian Diabetes in Pregnancy Follow-up Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04429958
Acronym
BEDIP-FUS
Enrollment
630
Registered
2020-06-12
Start date
2021-01-25
Completion date
2023-10-23
Last updated
2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes, Obesity, Type2 Diabetes

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.

Interventions

OTHERGDM

different degrees of hyperglycaemia during pregnancy

Sponsors

University Hospital, Antwerp
CollaboratorOTHER
Onze Lieve Vrouw Hospital
CollaboratorOTHER
Imelda Bonheiden
CollaboratorUNKNOWN
Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
A disorder of glucose metabolism in mothers3-7 years after deliveryT2DM defined by the 75g OGTT and/or HbA1c, or prediabetes defined by the American Diabetes Association (ADA) criteria
BMI in offspring3-7 years after deliveryBMI z score as a continuous variable

Secondary

MeasureTime frameDescription
Insulin sensitivity mothers Matsuda3-7 years after deliveryInsulin sensitivity measured by the insulin sensitivity index of Matsuda
Insulin sensitivity mothers HOMA3-7 years after deliveryInsulin sensitivity measured by the reciprocal of the homeostasis model assessment of insulin resistance (1/HOMA-IR)
Beta-cell function mothers HOMA-B3-7 years after deliveryBeta-cell function by the HOMA-B index and the insulinogenic index divided by HOMA-IR
Beta-cell function mothers ISSI-23-7 years after deliveryBeta-cell function measured by the insulin-secretion sensitivity-2 index
Beta-cell function mothers Stumvoll3-7 years after deliveryBeta-cell function measured by the Stumvoll index
Adiposity mothers BIA3-7 years after deliveryAdiposity (as a continuous variable) measured by the bioelectrical impedance analysis
Adiposity mothers skin folds3-7 years after deliveryAdiposity (as a continuous variable) measured by skin folds
BMI in mothers3-7 years after deliveryBMI as continuous variable
obesity offspring3-7 years after deliveryobesity defined by BMI z score according to the WHO guidelines
A disorder of glucose metabolism in offspring3-7 years after deliveryT2DM and prediabetes based on the fasting plasma glucoseand/or HbA1c defined by the ADA criteria
metabolic syndrome in offsping3-7 years after deliverymetabolic syndrome based on the WHO criteria
insulin sensitivity offspring3-7 years after deliveryinsulin sensitivity measured by HOMA-IR
Beta-cell function offsping3-7 years after deliveryBeta-cell function by the HOMA-B index
Adiposity offsping BIA3-7 years after deliveryAdiposity (as a continuous variable) measured by the bioelectrical impedance analysis
Adiposity offsping skin folds3-7 years after deliveryAdiposity (as a continuous variable) measured by skin folds
overweight offspring3-7 years after deliveryoverweight defined by BMI z score according to the WHO guidelines
metabolic syndrome in mothers3-7 years after deliveryThe metabolic syndrome based on the WHO criteria

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026