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Completed

NCT Number: NCT04429958

The Belgian Diabetes in Pregnancy Follow-up Study

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.

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Key information

Conditions

Gestational Diabetes Body Weight Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Type2 Diabetes Urogenital Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OLV-Alast, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDM

Other

different degrees of hyperglycaemia during pregnancy

Primary outcomes

  1. A disorder of glucose metabolism in mothers

    Time frame: 3-7 years after delivery

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

  2. BMI in offspring

    Time frame: 3-7 years after delivery

    BMI z score as a continuous variable

Secondary outcomes

  1. BMI in mothers

    Time frame: 3-7 years after delivery

    BMI as continuous variable

  2. metabolic syndrome in mothers

    Time frame: 3-7 years after delivery

    The metabolic syndrome based on the WHO criteria

  3. Insulin sensitivity mothers Matsuda

    Time frame: 3-7 years after delivery

    Insulin sensitivity measured by the insulin sensitivity index of Matsuda

  4. Insulin sensitivity mothers HOMA

    Time frame: 3-7 years after delivery

    Insulin sensitivity measured by the reciprocal of the homeostasis model assessment of insulin resistance (1/HOMA-IR)

  5. Beta-cell function mothers HOMA-B

    Time frame: 3-7 years after delivery

    Beta-cell function by the HOMA-B index and the insulinogenic index divided by HOMA-IR

  6. Beta-cell function mothers ISSI-2

    Time frame: 3-7 years after delivery

    Beta-cell function measured by the insulin-secretion sensitivity-2 index

  7. Beta-cell function mothers Stumvoll

    Time frame: 3-7 years after delivery

    Beta-cell function measured by the Stumvoll index

  8. Adiposity mothers BIA

    Time frame: 3-7 years after delivery

    Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis

  9. Adiposity mothers skin folds

    Time frame: 3-7 years after delivery

    Adiposity (as a continuous variable) measured by skin folds

  10. overweight offspring

    Time frame: 3-7 years after delivery

    overweight defined by BMI z score according to the WHO guidelines

  11. obesity offspring

    Time frame: 3-7 years after delivery

    obesity defined by BMI z score according to the WHO guidelines

  12. A disorder of glucose metabolism in offspring

    Time frame: 3-7 years after delivery

    T2DM and prediabetes based on the fasting plasma glucoseand/or HbA1c defined by the ADA criteria

  13. metabolic syndrome in offsping

    Time frame: 3-7 years after delivery

    metabolic syndrome based on the WHO criteria

  14. insulin sensitivity offspring

    Time frame: 3-7 years after delivery

    insulin sensitivity measured by HOMA-IR

  15. Beta-cell function offsping

    Time frame: 3-7 years after delivery

    Beta-cell function by the HOMA-B index

  16. Adiposity offsping BIA

    Time frame: 3-7 years after delivery

    Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis

  17. Adiposity offsping skin folds

    Time frame: 3-7 years after delivery

    Adiposity (as a continuous variable) measured by skin folds

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Imelda Bonheiden
  • Onze Lieve Vrouw Hospital
  • University Hospital, Antwerp

Registry information

Acronym: BEDIP-FUS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 12, 2020
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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