The Belgian Diabetes in Pregnancy Follow-up Study (BEDIP-FUS)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Type2 Diabetes; Gestational Diabetes
• Intervention / Treatment: Other: GDM

• Study Type: Observational
• Enrollment (Actual): 630

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • OLV-Alast
  • Antwerp, Belgium
    • UZA
  • Asse, Belgium
    • OLV-Asse
  • Bonheiden, Belgium
    • Imelda Bonheiden
  • Leuven, Belgium
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI in mothers	BMI as continuous variable	3-7 years after delivery
metabolic syndrome in mothers	The metabolic syndrome based on the WHO criteria	3-7 years after delivery
Insulin sensitivity mothers Matsuda	Insulin sensitivity measured by the insulin sensitivity index of Matsuda	3-7 years after delivery
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
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
Beta-cell function mothers ISSI-2	Beta-cell function measured by the insulin-secretion sensitivity-2 index	3-7 years after delivery
Beta-cell function mothers Stumvoll	Beta-cell function measured by the Stumvoll index	3-7 years after delivery
Adiposity mothers BIA	Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis	3-7 years after delivery
Adiposity mothers skin folds	Adiposity (as a continuous variable) measured by skin folds	3-7 years after delivery
overweight offspring	overweight defined by BMI z score according to the WHO guidelines	3-7 years after delivery
obesity offspring	obesity defined by BMI z score according to the WHO guidelines	3-7 years after delivery
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
metabolic syndrome in offsping	metabolic syndrome based on the WHO criteria	3-7 years after delivery
insulin sensitivity offspring	insulin sensitivity measured by HOMA-IR	3-7 years after delivery
Beta-cell function offsping	Beta-cell function by the HOMA-B index	3-7 years after delivery
Adiposity offsping BIA	Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis	3-7 years after delivery
Adiposity offsping skin folds	Adiposity (as a continuous variable) measured by skin folds	3-7 years after delivery

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: University Hospital, Antwerp; Onze Lieve Vrouw Hospital; Imelda Bonheiden
• Investigators: Principal Investigator: Katrien Benhalima, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): October 23, 2023
• Study Completion (Actual): October 23, 2023

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: S64070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No