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

October 31, 2023 updated by: Universitaire Ziekenhuizen KU Leuven
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
630

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3-7 years after delivery
BMI in offspring
Time Frame: 3-7 years after delivery
BMI z score as a continuous variable
3-7 years after delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BMI in mothers
Time Frame: 3-7 years after delivery
BMI as continuous variable
3-7 years after delivery
metabolic syndrome in mothers
Time Frame: 3-7 years after delivery
The metabolic syndrome based on the WHO criteria
3-7 years after delivery
Insulin sensitivity mothers Matsuda
Time Frame: 3-7 years after delivery
Insulin sensitivity measured by the insulin sensitivity index of Matsuda
3-7 years after delivery
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)
3-7 years after delivery
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
3-7 years after delivery
Beta-cell function mothers ISSI-2
Time Frame: 3-7 years after delivery
Beta-cell function measured by the insulin-secretion sensitivity-2 index
3-7 years after delivery
Beta-cell function mothers Stumvoll
Time Frame: 3-7 years after delivery
Beta-cell function measured by the Stumvoll index
3-7 years after delivery
Adiposity mothers BIA
Time Frame: 3-7 years after delivery
Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis
3-7 years after delivery
Adiposity mothers skin folds
Time Frame: 3-7 years after delivery
Adiposity (as a continuous variable) measured by skin folds
3-7 years after delivery
overweight offspring
Time Frame: 3-7 years after delivery
overweight defined by BMI z score according to the WHO guidelines
3-7 years after delivery
obesity offspring
Time Frame: 3-7 years after delivery
obesity defined by BMI z score according to the WHO guidelines
3-7 years after delivery
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
3-7 years after delivery
metabolic syndrome in offsping
Time Frame: 3-7 years after delivery
metabolic syndrome based on the WHO criteria
3-7 years after delivery
insulin sensitivity offspring
Time Frame: 3-7 years after delivery
insulin sensitivity measured by HOMA-IR
3-7 years after delivery
Beta-cell function offsping
Time Frame: 3-7 years after delivery
Beta-cell function by the HOMA-B index
3-7 years after delivery
Adiposity offsping BIA
Time Frame: 3-7 years after delivery
Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis
3-7 years after delivery
Adiposity offsping skin folds
Time Frame: 3-7 years after delivery
Adiposity (as a continuous variable) measured by skin folds
3-7 years after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Antwerp
Onze Lieve Vrouw Hospital
Imelda Bonheiden

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katrien Benhalima, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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