Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:20 PM
Study NCT ID:
NCT04429958
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2020-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Belgian Diabetes in Pregnancy Follow-up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 630}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A disorder of glucose metabolism in mothers', 'timeFrame': '3-7 years after delivery', 'description': 'T2DM defined by the 75g OGTT and/or HbA1c, or prediabetes defined by the American Diabetes Association (ADA) criteria'}, {'measure': 'BMI in offspring', 'timeFrame': '3-7 years after delivery', 'description': 'BMI z score as a continuous variable'}], 'secondaryOutcomes': [{'measure': 'BMI in mothers', 'timeFrame': '3-7 years after delivery', 'description': 'BMI as continuous variable'}, {'measure': 'metabolic syndrome in mothers', 'timeFrame': '3-7 years after delivery', 'description': 'The metabolic syndrome based on the WHO criteria'}, {'measure': 'Insulin sensitivity mothers Matsuda', 'timeFrame': '3-7 years after delivery', 'description': 'Insulin sensitivity measured by the insulin sensitivity index of Matsuda'}, {'measure': 'Insulin sensitivity mothers HOMA', 'timeFrame': '3-7 years after delivery', 'description': 'Insulin sensitivity measured by the reciprocal of the homeostasis model assessment of insulin resistance (1/HOMA-IR)'}, {'measure': 'Beta-cell function mothers HOMA-B', 'timeFrame': '3-7 years after delivery', 'description': 'Beta-cell function by the HOMA-B index and the insulinogenic index divided by HOMA-IR'}, {'measure': 'Beta-cell function mothers ISSI-2', 'timeFrame': '3-7 years after delivery', 'description': 'Beta-cell function measured by the insulin-secretion sensitivity-2 index'}, {'measure': 'Beta-cell function mothers Stumvoll', 'timeFrame': '3-7 years after delivery', 'description': 'Beta-cell function measured by the Stumvoll index'}, {'measure': 'Adiposity mothers BIA', 'timeFrame': '3-7 years after delivery', 'description': 'Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis'}, {'measure': 'Adiposity mothers skin folds', 'timeFrame': '3-7 years after delivery', 'description': 'Adiposity (as a continuous variable) measured by skin folds'}, {'measure': 'overweight offspring', 'timeFrame': '3-7 years after delivery', 'description': 'overweight defined by BMI z score according to the WHO guidelines'}, {'measure': 'obesity offspring', 'timeFrame': '3-7 years after delivery', 'description': 'obesity defined by BMI z score according to the WHO guidelines'}, {'measure': 'A disorder of glucose metabolism in offspring', 'timeFrame': '3-7 years after delivery', 'description': 'T2DM and prediabetes based on the fasting plasma glucoseand/or HbA1c defined by the ADA criteria'}, {'measure': 'metabolic syndrome in offsping', 'timeFrame': '3-7 years after delivery', 'description': 'metabolic syndrome based on the WHO criteria'}, {'measure': 'insulin sensitivity offspring', 'timeFrame': '3-7 years after delivery', 'description': 'insulin sensitivity measured by HOMA-IR'}, {'measure': 'Beta-cell function offsping', 'timeFrame': '3-7 years after delivery', 'description': 'Beta-cell function by the HOMA-B index'}, {'measure': 'Adiposity offsping BIA', 'timeFrame': '3-7 years after delivery', 'description': 'Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis'}, {'measure': 'Adiposity offsping skin folds', 'timeFrame': '3-7 years after delivery', 'description': 'Adiposity (as a continuous variable) measured by skin folds'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Diabetes', 'Type2 Diabetes', 'Obesity']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers who participated in the completed BEDIP-N study and received both the GCT as the OGTT during pregnancy\n* Offspring born at the time of participation in the BEDIP-N study\n\nExclusion Criteria:\n\n* Mothers:\n\n * Current pregnancy\n * Treatment that influences glycaemic status such as high dose corticoids.\n * History of bariatric surgery\n * gastro-intestinal surgery changing the absorption of glucose (Billroth II)\n * A normal study visit will not be possible (incompliance, psychiatric problems…)\n * Diagnosed with type 1 diabetes or the presence of auto-immune antibodies for type 1 diabetes\n\nOffspring:\n\n* Treatment that influences glycaemic status such as high dose corticoids.\n* A normal study visit will not be possible (incompliance, psychiatric problems…)\n* Diagnosed with type 1 diabetes or the presence of auto-immune antibodies for type 1 diabetes'}, 'identificationModule': {'nctId': 'NCT04429958', 'acronym': 'BEDIP-FUS', 'briefTitle': 'The Belgian Diabetes in Pregnancy Follow-up Study', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'The Belgian Diabetes in Pregnancy Follow-up Study', 'orgStudyIdInfo': {'id': 'S64070'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GDM', 'description': '125 mothers with a history of GDM in pregnancy at the time of the BEDIP study and their offspring born during the BEDIP study', 'interventionNames': ['Other: GDM']}, {'label': 'abnormal GCT group', 'description': '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'}, {'label': 'normal group', 'description': '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'}], 'interventions': [{'name': 'GDM', 'type': 'OTHER', 'description': 'different degrees of hyperglycaemia during pregnancy', 'armGroupLabels': ['GDM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'country': 'Belgium', 'facility': 'OLV-Alast', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'UZA', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Asse', 'country': 'Belgium', 'facility': 'OLV-Asse', 'geoPoint': {'lat': 50.91011, 'lon': 4.19836}}, {'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imelda Bonheiden', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Katrien Benhalima', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, {'name': 'Onze Lieve Vrouw Hospital', 'class': 'OTHER'}, {'name': 'Imelda Bonheiden', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}