Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-02 @ 11:01 AM
Study NCT ID:
NCT02796456
Status:
COMPLETED
Last Update Posted:
2018-06-13
First Post:
2016-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-12', 'studyFirstSubmitDate': '2016-05-19', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biological measure : Maternal apelinemia (Plasma Concentration)', 'timeFrame': 'between 35 and 41 weeks of gestation (WG)', 'description': 'plasma sample'}], 'secondaryOutcomes': [{'measure': 'Biological measure : Neonatal apelinemia (Plasma Concentration)', 'timeFrame': 'the day of the delivery', 'description': 'plasma sample'}, {'measure': 'Biological measure : Maternal apelinemia (Plasma Concentration)', 'timeFrame': 'the day of the delivery and 2 days after the delivery', 'description': 'plasma sample'}, {'measure': 'apelin level in the colostrum', 'timeFrame': '2 days after the delivery', 'description': 'colostrum sample'}, {'measure': 'C-peptide', 'timeFrame': 'between 35 and 41 weeks of gestation (WG) and 2 days after the delivery', 'description': 'maternal plasma sample'}, {'measure': 'glycemia', 'timeFrame': 'between 35 and 41 weeks of gestation (WG) and 2 days after the delivery', 'description': 'maternal plasma sample'}, {'measure': 'insulinemia', 'timeFrame': 'between 35 and 41 weeks of gestation (WG) and 2 days after the delivery', 'description': 'maternal plasma sample'}, {'measure': 'C-peptide', 'timeFrame': 'the day of the delivery', 'description': 'neonatal plasma sample'}, {'measure': 'glycemia', 'timeFrame': 'the day of the delivery', 'description': 'neonatal plasma sample'}, {'measure': 'insulinemia', 'timeFrame': 'the day of the delivery', 'description': 'neonatal plasma sample'}, {'measure': 'total cholesterol', 'timeFrame': 'between 35 and 41 weeks of gestation (WG) and 2 days after the delivery', 'description': 'maternal plasma sample'}, {'measure': 'HDL', 'timeFrame': 'between 35 and 41 weeks of gestation (WG) and 2 days after the delivery', 'description': 'maternal plasma sample'}, {'measure': 'LDL', 'timeFrame': 'between 35 and 41 weeks of gestation (WG) and 2 days after the delivery', 'description': 'maternal plasma sample'}, {'measure': 'triglycerides', 'timeFrame': 'between 35 and 41 weeks of gestation (WG) and 2 days after the delivery', 'description': 'maternal plasma sample'}, {'measure': 'apolipoprotein A', 'timeFrame': 'between 35 and 41 weeks of gestation (WG) and 2 days after the delivery', 'description': 'maternal plasma sample'}, {'measure': 'apolipoprotein B', 'timeFrame': 'between 35 and 41 weeks of gestation (WG) and 2 days after the delivery', 'description': 'maternal plasma sample'}, {'measure': 'total cholesterol', 'timeFrame': 'the day of the delivery', 'description': 'neonatal plasma sample'}, {'measure': 'Biological measure : HDL', 'timeFrame': 'the day of the delivery', 'description': 'neonatal plasma sample'}, {'measure': 'Biological measure : LDL', 'timeFrame': 'the day of the delivery', 'description': 'neonatal plasma sample'}, {'measure': 'triglycerides', 'timeFrame': 'the day of the delivery', 'description': 'neonatal plasma sample'}, {'measure': 'apolipoprotein A', 'timeFrame': 'the day of the delivery', 'description': 'neonatal plasma sample'}, {'measure': 'apolipoprotein B', 'timeFrame': 'the day of the delivery', 'description': 'neonatal plasma sample'}, {'measure': 'BMI', 'timeFrame': 'at baseline', 'description': 'measure maternal gain of weight before pregnancy and during pregnancy in maternal declaration'}, {'measure': 'Infant weight', 'timeFrame': 'within 2 days of postpartum'}, {'measure': 'Infant size', 'timeFrame': 'within 5 days of postpartum'}, {'measure': 'Placenta weight', 'timeFrame': 'the days of the delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['apelin', 'colostrum', 'plasma', 'glycemic markers', 'lipidic markers', 'pregnancy', 'postpartum'], 'conditions': ['Obesity', 'Pregnancy', 'Gestational Diabetes']}, 'descriptionModule': {'briefSummary': "Background :\n\nApelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity. Little is known about the function of the apelinergic system during gestation.\n\nObjective :\n\nThe main objective of this study is to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).\n\nStrategy and method:\n\nA prospective research evaluating will be conducted to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).\n\nA third group will be created to check if gestational diabetes is not a confounding factor in obesity (group of obese women with gestational diabetes).\n\nInvestigators will try to see if apelinemia is correlated to lipidic and glycemic markers.\n\nSamples will be collected in the cord blood to compare maternal and neonatal apelinemia and to see if neonatal apelinemia is correlated to the child's weight and birth size and to the weight of the placenta.\n\nPlacenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.\n\nTwo days after delivery, obese and not obese women will be fasted and plasma and colostrum will be collected. Investigators will compare apelin levels in the colostrum between these 2 groups and then investigators will try to see if apelin level is correlated in the colostrum and in maternal plasma.", 'detailedDescription': 'Background :\n\nApelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity.\n\nLittle is known about the function of the apelinergic system during gestation.\n\nIn a previous study, investigators evaluated in mice this system at the feto-maternal interface in insulin-resistant obese female (HF) mice. Maternal apelinemia was decreased at term and fetal apelinemia was sixfold higher than maternal level. Ex-vivo, the placenta releases high amount of apelin at E12.5 and E18.5. In HF pregnant mice at term, apelinemia as well as placental apelin and APJ mRNA levels were increased whereas placental release of apelin was drastically reduced.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women between 18 and 42 years old, pregnant, between 35 and 40 WG.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Obese pregnant women\n* Age from 18 to 42 years old\n* Singleton pregnancy between 35+0 to 41+6 weeks of pregnancy\n\nExclusion Criteria:\n\n* Severe heart, liver or kidney disease\n* Multiple pregnancy\n* Hypertension, preeclampsia, small for gestational age\n* Pre-gestational diabetes\n* Bariatric surgery\n* Medication other than normal pregnancy supplementations\n* Tabacco or drugs consummation during pregnancy\n* Provided artificial feeding\n* Fetal anoxia with cord pH less than 7.0\n* Genetic or chromosomal mother's and / or newborn's abnormality\n* Fetal malformation\n* Trusteeship or tutorship\n* Refusal to participate in research\n* Unable to attend the entire study"}, 'identificationModule': {'nctId': 'NCT02796456', 'acronym': 'OB-APE', 'briefTitle': 'Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy', 'orgStudyIdInfo': {'id': '2014_70'}, 'secondaryIdInfos': [{'id': '2015-A01696-43', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal weight women', 'description': 'BMI between 18.5 and 25 kg/m2 and without gestational diabetes', 'interventionNames': ['Other: blood sample']}, {'label': 'Obese women without gestational diabetes', 'description': 'BMI more than 30 kg/m2 and without gestational diabetes', 'interventionNames': ['Other: blood sample']}, {'label': 'Obese women with gestational diabetes', 'description': 'BMI more than 30 kg/m2 and with gestational diabetes', 'interventionNames': ['Other: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'OTHER', 'armGroupLabels': ['Normal weight women', 'Obese women with gestational diabetes', 'Obese women without gestational diabetes']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Jeanne de Flandre - CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Philippe Deruelle, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}