The Belgian Diabetes in Pregnancy Follow-up Study

NCT ID: NCT04429958

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

630 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-25

Study Completion Date

2023-10-23

Brief Summary

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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.

Detailed Description

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Conditions

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Gestational Diabetes Type2 Diabetes Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GDM

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

GDM

Intervention Type OTHER

different degrees of hyperglycaemia during pregnancy

abnormal GCT group

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

No interventions assigned to this group

normal group

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

No interventions assigned to this group

Interventions

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GDM

different degrees of hyperglycaemia during pregnancy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role collaborator

Onze Lieve Vrouw Hospital

OTHER

Sponsor Role collaborator

Imelda Bonheiden

UNKNOWN

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katrien Benhalima

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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OLV-Alast

Aalst, , Belgium

Site Status

UZA

Antwerp, , Belgium

Site Status

OLV-Asse

Asse, , Belgium

Site Status

Imelda Bonheiden

Bonheiden, , Belgium

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S64070

Identifier Type: -

Identifier Source: org_study_id

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