The Belgian Diabetes in Pregnancy Follow-up Study

Completed

• Conditions: Gestational Diabetes; Type2 Diabetes; Obesity
• Interventions: Other: GDM

• Registration Number: NCT04429958
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-12
• Study Start: 2021-01-25
• Status Verified: 2023-10
• Primary Completion: 2023-10-23
• Study Completion: 2023-10-23
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 630

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GDM	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

Primary Outcome Measures

Name	Time	Method
BMI in offspring	3-7 years after delivery	BMI z score as a continuous variable
A disorder of glucose metabolism in mothers	3-7 years after delivery	T2DM defined by the 75g OGTT and/or HbA1c, or prediabetes defined by the American Diabetes Association (ADA) criteria

Secondary Outcome Measures

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

Trial Locations

Locations (5)

UZA; 🇧🇪 Antwerp, Belgium

OLV-Asse; 🇧🇪 Asse, Belgium

OLV-Alast; 🇧🇪 Aalst, Belgium

Imelda Bonheiden; 🇧🇪 Bonheiden, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium