Gestational DiabetesBEDIP-FUSNCT04429958
The Belgian Diabetes in Pregnancy Follow-up Study
An observational study of Gestational Diabetes and Type2 Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 5 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Gestational Diabetes, Type2 Diabetes, Obesity
- What is being tested?
- GDM
- How many people
- 630 participants
- Where
- 5 sitesBelgium
- Study dates
- 25 Jan 2021to 23 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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…)
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
OLV-Alast
Aalst
UZA
Antwerp
OLV-Asse
Asse
Imelda Bonheiden
Bonheiden
UZ Leuven
Leuven
About this 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.
- Conditions
- Gestational Diabetes, Type2 Diabetes, Obesity
- Being tested
- GDM
- Medical subject headings
- Diabetes, Gestational, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDMOther
different degrees of hyperglycaemia during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: GDM | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3-7 years after delivery
BMI in offspring
BMI z score as a continuous variable
Measured: 3-7 years after delivery
Secondary outcomes (17)
BMI in mothers
BMI as continuous variable
Measured: 3-7 years after delivery
metabolic syndrome in mothers
The metabolic syndrome based on the WHO criteria
Measured: 3-7 years after delivery
Insulin sensitivity mothers Matsuda
Insulin sensitivity measured by the insulin sensitivity index of Matsuda
Measured: 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)
Measured: 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
Measured: 3-7 years after delivery
Beta-cell function mothers ISSI-2
Beta-cell function measured by the insulin-secretion sensitivity-2 index
Measured: 3-7 years after delivery
Beta-cell function mothers Stumvoll
Beta-cell function measured by the Stumvoll index
Measured: 3-7 years after delivery
Adiposity mothers BIA
Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis
Measured: 3-7 years after delivery
Adiposity mothers skin folds
Adiposity (as a continuous variable) measured by skin folds
Measured: 3-7 years after delivery
overweight offspring
overweight defined by BMI z score according to the WHO guidelines
Measured: 3-7 years after delivery
obesity offspring
obesity defined by BMI z score according to the WHO guidelines
Measured: 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
Measured: 3-7 years after delivery
metabolic syndrome in offsping
metabolic syndrome based on the WHO criteria
Measured: 3-7 years after delivery
insulin sensitivity offspring
insulin sensitivity measured by HOMA-IR
Measured: 3-7 years after delivery
Beta-cell function offsping
Beta-cell function by the HOMA-B index
Measured: 3-7 years after delivery
Adiposity offsping BIA
Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis
Measured: 3-7 years after delivery
Adiposity offsping skin folds
Adiposity (as a continuous variable) measured by skin folds
Measured: 3-7 years after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start25 Jan 2021
- Primary completion23 Oct 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, Onze Lieve Vrouw Hospital, Imelda Bonheiden
- Responsible party
- Sponsor
- Investigators
- Katrien Benhalima, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429958
- Sponsor's protocol ID
- S64070
- Acronym
- BEDIP-FUS
- Status last verified
- Oct 2023
- First submitted
- 10 Jun 2020
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Belgian Diabetes in Pregnancy Follow-up Study
- ClinicalTrials.gov ID
- NCT04429958
- Acronym / sponsor ID
- BEDIP-FUS / S64070
- Conditions
- Gestational Diabetes, Type2 Diabetes, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, Onze Lieve Vrouw Hospital, Imelda Bonheiden
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GDM | – | Other: GDM125 mothers with a history of GDM in pregnancy at the time of the BEDIP study and their offspring born during the BEDIP study |
| 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 |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- Mothers:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDMdifferent degrees of hyperglycaemia during pregnancy | Other | GDM |
Primary outcome
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
BMI in offspring
Time frame: 3-7 years after delivery
BMI z score as a continuous variable
17 secondary outcomes
BMI in mothers
Time frame: 3-7 years after delivery
metabolic syndrome in mothers
Time frame: 3-7 years after delivery
Insulin sensitivity mothers Matsuda
Time frame: 3-7 years after delivery
Insulin sensitivity mothers HOMA
Time frame: 3-7 years after delivery
Beta-cell function mothers HOMA-B
Time frame: 3-7 years after delivery
Beta-cell function mothers ISSI-2
Time frame: 3-7 years after delivery
Beta-cell function mothers Stumvoll
Time frame: 3-7 years after delivery
Adiposity mothers BIA
Time frame: 3-7 years after delivery
Adiposity mothers skin folds
Time frame: 3-7 years after delivery
overweight offspring
Time frame: 3-7 years after delivery
obesity offspring
Time frame: 3-7 years after delivery
A disorder of glucose metabolism in offspring
Time frame: 3-7 years after delivery
metabolic syndrome in offsping
Time frame: 3-7 years after delivery
insulin sensitivity offspring
Time frame: 3-7 years after delivery
Beta-cell function offsping
Time frame: 3-7 years after delivery
Adiposity offsping BIA
Time frame: 3-7 years after delivery
Adiposity offsping skin folds
Time frame: 3-7 years after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrien Benhalima principal investigator
UZ Leuven
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Type2 Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A disorder of glucose metabolism in mothers (time frame: 3-7 years after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.