The Belgian Diabetes in Pregnancy Follow-up Study

Obesity Clinical Trial

— BEDIP-FUS  

Official title:

The Belgian Diabetes in Pregnancy Follow-up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04429958
• Other study ID #: S64070
• Status: Completed
• Start date: January 25, 2021
• Est. completion date: October 23, 2023

Study information

• Verified date: October 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: October 23, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Obesity
• Pregnancy in Diabetics
• Type2 Diabetes

Intervention

Other:
• GDM
different degrees of hyperglycaemia during pregnancy

Locations

Country	Name	City	State
Belgium	OLV-Alast	Aalst
Belgium	UZA	Antwerp
Belgium	OLV-Asse	Asse
Belgium	Imelda Bonheiden	Bonheiden
Belgium	UZ Leuven	Leuven

Sponsors (4)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Imelda Bonheiden, Onze Lieve Vrouw Hospital, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	BMI in offspring	BMI z score as a continuous variable	3-7 years after delivery
Secondary	BMI in mothers	BMI as continuous variable	3-7 years after delivery
Secondary	metabolic syndrome in mothers	The metabolic syndrome based on the WHO criteria	3-7 years after delivery
Secondary	Insulin sensitivity mothers Matsuda	Insulin sensitivity measured by the insulin sensitivity index of Matsuda	3-7 years after delivery
Secondary	Insulin sensitivity mothers HOMA	Insulin sensitivity measured by the reciprocal of the homeostasis model assessment of insulin resistance (1/HOMA-IR)	3-7 years after delivery
Secondary	Beta-cell function mothers HOMA-B	Beta-cell function by the HOMA-B index and the insulinogenic index divided by HOMA-IR	3-7 years after delivery
Secondary	Beta-cell function mothers ISSI-2	Beta-cell function measured by the insulin-secretion sensitivity-2 index	3-7 years after delivery
Secondary	Beta-cell function mothers Stumvoll	Beta-cell function measured by the Stumvoll index	3-7 years after delivery
Secondary	Adiposity mothers BIA	Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis	3-7 years after delivery
Secondary	Adiposity mothers skin folds	Adiposity (as a continuous variable) measured by skin folds	3-7 years after delivery
Secondary	overweight offspring	overweight defined by BMI z score according to the WHO guidelines	3-7 years after delivery
Secondary	obesity offspring	obesity defined by BMI z score according to the WHO guidelines	3-7 years after delivery
Secondary	A disorder of glucose metabolism in offspring	T2DM and prediabetes based on the fasting plasma glucoseand/or HbA1c defined by the ADA criteria	3-7 years after delivery
Secondary	metabolic syndrome in offsping	metabolic syndrome based on the WHO criteria	3-7 years after delivery
Secondary	insulin sensitivity offspring	insulin sensitivity measured by HOMA-IR	3-7 years after delivery
Secondary	Beta-cell function offsping	Beta-cell function by the HOMA-B index	3-7 years after delivery
Secondary	Adiposity offsping BIA	Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis	3-7 years after delivery
Secondary	Adiposity offsping skin folds	Adiposity (as a continuous variable) measured by skin folds	3-7 years after delivery