The Belgian Diabetes in Pregnancy Follow-up Study

Study Overview
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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.

Official Title
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The Belgian Diabetes in Pregnancy Follow-up Study

Conditions
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Obesity, Type2 Diabetes, Gestational Diabetes

Intervention / Treatment
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* Other: GDM


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GDM<br>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<br>* different degrees of hyperglycaemia during pregnancy<br>|
| abnormal GCT group<br>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<br>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?
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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 |