Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-06 @ 12:52 PM
Study NCT ID:
NCT05528393
Status:
UNKNOWN
Last Update Posted:
2022-09-06
First Post:
2022-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prolactin and FGF21 in Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-02', 'studyFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gestational diabetes mellitus (GDM)', 'timeFrame': '2019-2023', 'description': 'GDM is defined as a glucose intolerance resulting in hyperglycaemia of variable severity with onset during pregnancy. It can be diagnosed by the criteria: a fasting plasma glucose (FPG) concentration of O126 mg/dl on two separate occasions or a random blood glucose concentration of O200 mg/dl on two separate occasions.'}, {'measure': 'PRL', 'timeFrame': '2019-2023', 'description': 'serum prolactin level'}], 'secondaryOutcomes': [{'measure': 'Insulin resistance (IR)', 'timeFrame': '2019-2023', 'description': 'It was considered to be IR if HOMA-IR \\>2.5'}, {'measure': 'HOMA-IR', 'timeFrame': '2019-2023', 'description': 'It was calculated as: fasting plasma glucose (FPG) x fasting insulin (FINS)/22.5'}, {'measure': 'OGTT', 'timeFrame': '2019-2023', 'description': 'OGTT was performed after an overnight fasting in each patient and blood samples were taken at 0, 30, 60, 120, and 180 min to determine the concentrations of plasma glucose.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gestational Diabetes Mellitus', 'Prolactin', 'Insulin resistance', 'Fibroblast growth factor 21'], 'conditions': ['Gestational Diabetes Mellitus in Pregnancy', 'Hyperprolactinemia Pregnancy']}, 'descriptionModule': {'briefSummary': 'Prolactin (PRL) and PRL receptor (PRLR) signaling has been validated to play an important role in the modulation of glucolipid metabolism. However, the role of serum PRL levels in gestational diabetes mellitus (GDM) remains unclear. The investigators aimed to explore the possible influence of serum PRL within or without normal range on the development of GDM.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who met the above criteria were enrolled', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 to 45 years\n* completed a 75-g oral glucose tolerance test (OGTT)\n* females with pregnancy\n\nExclusion Criteria:\n\n* severe liver and renal dysfunction, preexisting heart disease, malignancy, or endocrine diseases such as pituitary adenoma and hypogonadism\n* mental illness\n* genetic disease\n* current or previous treatment that might affect PRL and insulin secretion\n* diabetes before pregnancy\n* loss to follow-up, or withdrawal from the study\n* unable to understand and comply with the study protocol.'}, 'identificationModule': {'nctId': 'NCT05528393', 'briefTitle': 'Prolactin and FGF21 in Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Prolactin and FGF21 in Gestational Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'gestational diabetes mellitus'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GDM and Non-GDM', 'interventionNames': ['Diagnostic Test: Blood sampling']}, {'label': 'Pregnant group and non-pregnant group', 'interventionNames': ['Diagnostic Test: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood sampling', 'armGroupLabels': ['GDM and Non-GDM', 'Pregnant group and non-pregnant group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shen Qu, PhD', 'role': 'CONTACT', 'email': 'qushencn@hotmail.com', 'phone': '+862166301064'}], 'facility': "Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shen Qu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Shen Qu', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}