Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04617405
Status:
UNKNOWN
Last Update Posted:
2022-11-23
First Post:
2020-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hormonal and Inflammatory Changes During Pregnancy in Women With Glucose Metabolic Disorders.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D011254', 'term': 'Pregnancy in Diabetics'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'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': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-22', 'studyFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in serum or plasma concentration of metabolic, hormonal and inflammatory markers at four other times during pregnancy.', 'timeFrame': 'Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38', 'description': 'Serum concentration of IGF-1, IGFBP-3, IGFBP-1, FGF-21, Leptin, Adiponectin, CD163, Human Chorionic Gonadotropin, Progesterone, C-peptide, Cortisol, Prolactin, Sex Hormone Binding Globulin, Estradiol, Free fatty acids, Human Placental Lactogen and Human Placental Growth Hormone.\n\nPlasma concentrations of IL-6, IL-10, IL-1alpha, IFN-gamma, TNF-alpha, ICAM1, VCAM, LDL, HDL, Triglyceride, Gamma-Glutamyl Transferase, Thyrotropin, glucose and HbA1c.'}, {'measure': 'Assocation between the serum or plasma concentration of metabolic, hormonal and inflammatory markers Versus Insulin sensitivity at five times during pregnancy.', 'timeFrame': 'Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38', 'description': 'Association between the metabolic, hormonal and inflammatory markers listed as Primary Outcome 1 and the Insulin sensitivity. Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting insulin and glucose concentrations.'}, {'measure': 'Changes from baseline in the level, content and bioactivity of exosomes in serum and plasma at four other times during pregnancy.', 'timeFrame': 'Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38', 'description': 'Exosomes will be isolated and profiling of the content will be performed using SWATH mass spectrometry and miRNA sequencing.'}, {'measure': 'Association between the level, content and bioactivity of exosomes in serum and plasma Versus Insulin sensitivity at five times during pregnancy.', 'timeFrame': 'Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38', 'description': 'Exosomes will be isolated and profiling of the content will be performed using SWATH mass spectrometry and miRNA sequencing. Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting insulin and glucose concentrations.'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in blood pressure (systolic and diastolic) at four other times during pregnancy.', 'timeFrame': 'Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38', 'description': 'Blood pressure includes the measurement of both systolic and diastolic blood pressure (mmHg).'}, {'measure': 'Changes from baseline in body weight at four other times during pregnancy.', 'timeFrame': 'Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38', 'description': 'Body weight measured in kilograms.'}, {'measure': 'Association between the blood pressure (systolic and diastolic) Versus Insulin sensitivity at five times during pregnancy.', 'timeFrame': 'Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38', 'description': 'Blood pressure includes the measurement of both systolic and diastolic blood pressure (mmHg). Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting insulin and glucose concentrations.'}, {'measure': 'Association between the body weight Versus Insulin sensitivity at five times during pregnancy.', 'timeFrame': 'Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38', 'description': 'Body weight measured in kilograms. Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting insulin and glucose concentrations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Gestational Diabetes', 'Overweight and Obesity', 'Pregnancy in Diabetic', 'Insulin Resistance', 'Insulin Sensitivity', 'Pregnancy, High Risk']}, 'descriptionModule': {'briefSummary': 'The first aim of this study is to describe maternal hormonal and inflammatory changes during pregnancy in women that differ metabolically (limited to women with type 2 diabetes, gestational diabetes and/or overweight). The second aim of this study is to examine maternal hormonal, inflammatory and metabolic factors associated with insulin sensitivity in human pregnancy.', 'detailedDescription': "This is a prospective observational study including app. 300 pregnant women from the outpatient clinics at Department of Obstetrics and Gynecology at Aalborg, Odense and Aarhus University Hospital.\n\nThe study includes 50 healthy normal-weight women, 150 healthy overweight women, 50 women with gestational diabetes and 50 women with type 2 diabetes.\n\nHormonal profiles and inflammatory markers will be measured at gestational week 8-10, 10-14, 18-22, 24-28 and 34-38. The blood samples will include HbA1c, glukose, insulin, C-peptid, lipid profile, liver enzymes, creatinine, FGF-21, TSH, Cortisol, human chorionic gonadotropin, estradiol, progesterone, prolactin, human placental lactogen, placental growth hormone, IGF-1, IGF-BP's, Leptin, Adiponectin, GLP-1, GIP, hs-CRP, IL-6, IL-10, IL-1α, IFN-ɣ, TNF-α, ICAM1, VCAM and CD163. In addition to this, exosomes will be isolated precisely and profiling of the content of exosomes will be performed using in vitro assays. Proteomics and miRNAs sequencing will be employed.\n\nHeight, weight, and blood pressure will be measured at every visit and a urine sample will be collected.\n\nInsulin sensitivity will be estimated using the homeostasis model assessment, IS-HOMA, based on fasting insulin and glucose concentrations."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consist of pregnant women followed at The Department of Gynaecology and Obstetrics at Aarhus University Hospital, Aalborg University Hospital or Odense University Hospital. Cases are either healthy with a BMI \\>= 25, diagnosed with gestational diabetes before gestational week 20 or diagnosed with pregestational type 2 diabetes. Controls are healthy with a BMI \\< 25.', 'genderDescription': 'Only pregnant women are eligible for participation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women at The Department of Gynaecology and Obstetrics at Aarhus University Hospital, Aalborg University Hospital or Odense University Hospital.\n* Women have to be in 1 of 4 categories: Healthy with a BMI \\< 25, healthy with a BMI \\>= 25, diagnosed with gestational diabetes before gestational week 20 or diagnosed with pregestational type 2 diabetes\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Not able to read and understand danish\n* Previous bariatric surgery\n* Treatment with systemic corticosteroids'}, 'identificationModule': {'nctId': 'NCT04617405', 'acronym': 'HI-MET', 'briefTitle': 'Hormonal and Inflammatory Changes During Pregnancy in Women With Glucose Metabolic Disorders.', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Hormonal and Inflammatory Changes During Pregnancy in Women With Glucose Metabolic Disorders.', 'orgStudyIdInfo': {'id': 'PADME1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type A', 'description': 'Healthy normal-weight pregnant women', 'interventionNames': ['Other: No interventions']}, {'label': 'Type B', 'description': 'Pregnant women with gestational diabetes diagnosed at early screening (before gestational week 20)', 'interventionNames': ['Other: No interventions']}, {'label': 'Type C', 'description': 'Pregnant women with type 2 diabetes', 'interventionNames': ['Other: No interventions']}, {'label': 'Type D', 'description': 'Healthy overweight pregnant women', 'interventionNames': ['Other: No interventions']}], 'interventions': [{'name': 'No interventions', 'type': 'OTHER', 'description': 'No interventions', 'armGroupLabels': ['Type A', 'Type B', 'Type C', 'Type D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Anna S Koefoed, M.D.', 'role': 'CONTACT', 'email': 'annask@clin.au.dk', 'phone': '+45 93 50 80 69'}, {'name': 'Per G Ovesen, Prof., M.D.', 'role': 'CONTACT', 'email': 'perovese@rm.dk'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '9100', 'city': 'Aalborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Anne W Sørensen, M.D.', 'role': 'CONTACT', 'email': 'anns@rn.dk', 'phone': '+45 93 50 80 69'}], 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '5000', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lise Lotte T Andersen, MD', 'role': 'CONTACT', 'email': 'lise.lotte.andersen@rsyd.dk', 'phone': '+45 93 50 80 69'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Anna S Koefoed, M.D.', 'role': 'CONTACT', 'email': 'annask@clin.au.dk', 'phone': '+45 93 50 80 69'}, {'name': 'Per G Ovesen, Prof., M.D.', 'role': 'CONTACT', 'email': 'perovese@rm.dk'}], 'overallOfficials': [{'name': 'Anna S Koefoed, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University, Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'The University of Queensland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}