The Belgian Diabetes in Pregnancy Follow-up Study

NCT04429958 | Completed

• 1 other identifier: S64070
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 5

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.

Conditions

Gestational Diabetes; Type2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (2)

• A disorder of glucose metabolism in mothers

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

  3-7 years after delivery

• BMI in offspring

  BMI z score as a continuous variable

  3-7 years after delivery

Secondary Outcomes (17)

• BMI in mothers

  3-7 years after delivery

• metabolic syndrome in mothers

  3-7 years after delivery

• Insulin sensitivity mothers Matsuda

  3-7 years after delivery

• Insulin sensitivity mothers HOMA

  3-7 years after delivery

• Beta-cell function mothers HOMA-B

  3-7 years after delivery

Study Arms (3)

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

Other: GDM

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

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

Interventions

GDM OTHER

different degrees of hyperglycaemia during pregnancy

GDM

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• University Hospital, Antwerp: collaborator
• Onze Lieve Vrouw Hospital: collaborator
• Imelda Bonheiden: collaborator

Study Sites (5)

OLV-Alast

Aalst, Belgium

Location

UZA

Antwerp, Belgium

Location

OLV-Asse

Asse, Belgium

Location

Imelda Bonheiden

Bonheiden, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Diabetes, Gestational; Obesity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katrien Benhalima

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: January 25, 2021
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5)