Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-15 @ 3:55 PM
Study NCT ID:
NCT06802861
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D000079262', 'term': 'Pregnancy in Obesity'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hexadecadienoate (z score)', 'timeFrame': '60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age', 'description': 'Hexadecadienoate (long chain poly unsaturated fatty acid metabolite obtained from metabolomics assay) (z score)'}, {'measure': 'Salicylate (z score)', 'timeFrame': '60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age', 'description': 'Salicylate (benzoate metabolite obtained from metabolomics assay)(z score)'}], 'secondaryOutcomes': [{'measure': 'Urinary thromboxane B2 level (pg/mg creat)', 'timeFrame': '60 minutes after ingestion of 75 grams of glucose, during a single study visit between 14-20 weeks gestational age', 'description': 'Urinary thromboxane B2 level (pg/mg creat)'}, {'measure': 'Fasting Salicylate level (ug/mL)', 'timeFrame': 'Fasting, at the beginning of a single study visit between 14-20 weeks gestational age', 'description': 'Fasting Salicylate level (ug/mL) in venous blood'}, {'measure': '1 Hour Salicylate level (ug/mL)', 'timeFrame': '60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age', 'description': '1 Hour Salicylate level (ug/mL) in venous blood'}, {'measure': '2 Hour Salicylate level (ug/mL)', 'timeFrame': '120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age', 'description': '2 Hour Salicylate level (ug/mL) in venous blood'}, {'measure': 'Fasting PFA-100 epinephrine closure time', 'timeFrame': 'Fasting, at the beginning of a single study visit between 14-20 weeks gestational age', 'description': 'Fasting PFA-100 epinephrine closure time in venous blood'}, {'measure': '1 Hour PFA-100 epinephrine closure time', 'timeFrame': '60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age', 'description': '1 Hour PFA-100 epinephrine closure time in venous blood'}, {'measure': '2 Hour PFA-100 epinephrine closure time', 'timeFrame': '120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age', 'description': '2 Hour PFA-100 epinephrine closure time in venous blood'}, {'measure': 'Homeostatic Model Assessment for Insulin Resistance', 'timeFrame': 'Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 14-20 weeks gestational age', 'description': 'Approximates insulin resistance.'}, {'measure': 'Fasting Resting Metabolic Rate', 'timeFrame': 'Measured at the start of a single study visit between 14-20 weeks gestational age', 'description': 'Resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry'}, {'measure': 'Fasting Respiratory Quotient', 'timeFrame': 'Measured at the start of a single study visit between 14-20 weeks gestational age', 'description': 'Resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry'}, {'measure': 'Fasting Carbohydrate Oxidation Rate', 'timeFrame': 'Measured at the start of a single study visit between 14-20 weeks gestational age', 'description': 'Fasting carbohydrate oxidation rate measures whole body carbohydrate oxidation, which is assessed using indirect calorimetry'}, {'measure': 'Fasting Lipid Oxidation Rate', 'timeFrame': 'Measured at the start of a single study visit between 14-20 weeks gestational age', 'description': 'Fasting lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry'}, {'measure': 'Fasting Insulin (mIU/mL)', 'timeFrame': 'Fasting, at the beginning of a single study visit between 14-20 weeks gestational age', 'description': 'Fasting insulin level (mIU/mL) in venous blood'}, {'measure': 'Fasting glucose (mg/dL)', 'timeFrame': 'Fasting, at the beginning of a single study visit between 14-20 weeks gestational age', 'description': 'Fasting glucose level (mg/dL) in venous blood'}, {'measure': 'Fasting lactate (mmol/L)', 'timeFrame': 'Fasting, at the beginning of a single study visit between 14-20 weeks gestational age', 'description': 'Fasting lactate level (mmol/L) in venous blood'}, {'measure': 'Fasting triglycerides (mg/dL)', 'timeFrame': 'Fasting, at the beginning of a single study visit between 14-20 weeks gestational age', 'description': 'Fasting triglycerides level (mg/dL) in venous blood'}, {'measure': 'Fasting high density lipoprotein (mg/dL)', 'timeFrame': 'Fasting, at the beginning of a single study visit between 14-20 weeks gestational age', 'description': 'Fasting high density lipoprotein level (HDL) (mg/dL) in venous blood'}, {'measure': 'Fasting very low density lipoprotein (mg/dL)', 'timeFrame': 'Fasting, at the beginning of a single study visit between 14-20 weeks gestational age', 'description': 'Fasting very low density lipoprotein level (VLDL) (mg/dL) in venous blood'}, {'measure': 'Fasting low density lipoprotein (mg/dL)', 'timeFrame': 'Fasting, at the beginning of a single study visit between 14-20 weeks gestational age', 'description': 'Fasting low density lipoprotein level (LDL) (mg/dL) in venous blood'}, {'measure': 'Fasting cholesterol (mg/dL)', 'timeFrame': 'Fasting, at the beginning of a single study visit between 14-20 weeks gestational age', 'description': 'Fasting cholesterol level (mg/dL) in venous blood'}, {'measure': 'Fasting free fatty acids (mEq/L)', 'timeFrame': 'Fasting, at the beginning of a single study visit between 14-20 weeks gestational age', 'description': 'Fasting free fatty acids (FFA) (mEq/L) in venous blood'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metabolic dysfunction', 'gestational diabetes', 'pregnancy', 'maternal obesity', 'maternal insulin resistance', 'aspirin metabolism', 'GDM', 'substrate oxidation', 'gestational glucose intolerance'], 'conditions': ['Preeclampsia', 'Preeclampsia (PE)', 'Preeclampsia (PE) Risk', 'Obesity and Obesity-related Medical Conditions', 'Pregnancy', 'Pregnancy Complications', 'Gestational Diabetes', 'Gestational Diabetes Mellitus in Pregnancy', 'Gestational Complications']}, 'descriptionModule': {'briefSummary': "This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant individuals at risk for preeclampsia', 'genderDescription': 'Limited to the biological sex of female, during pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recommended aspirin for pre-eclampsia prevention by OB/GYN or MFM specialist based on ACOG and USPSTF guidelines (1 high risk factor, 2+ moderate risk factors)\n\n * Willingness to adhere to aspirin therapy\n * Willingness to undergo 2h OGTT for serum and urine collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc.\n * Gestational age at enrollment \\<16 weeks\n * Ability to speak, read, and communicate via English\n\nExclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n\n * Type 1 Diabetes Mellitus\n * Current gestational diabetes mellitus\n * Current/active platelet disorder or bleeding diathesis (thrombocytopenia of any etiology, idiopathic thrombocytopenic purpura/ITP, thrombotic thrombocytopenic purpura/TTP, von Willebrand disease, etc.)\n * Thrombophilia\n * Current use of NSAID for other indication (indomethacin, ibuprofen, etc.)\n * Current use of other immune-modulating agents and biologics (hydroxychloroquine, azathioprine, 6-mercaptopurine, IL-6 inhibitors, etc.)\n * Current or recent use of steroids\n * Current use of prophylactic or therapeutic anticoagulation\n * Medical contraindication to aspirin therapy\n * Molar pregnancy\n * Renal disease\n * Inability or unwillingness to give informed consent\n * Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principal investigators'}, 'identificationModule': {'nctId': 'NCT06802861', 'acronym': 'RAMP', 'briefTitle': 'Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee Graduate School of Medicine'}, 'officialTitle': 'Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia', 'orgStudyIdInfo': {'id': '5316'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant individuals at risk for preecampsia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Purvis, MD', 'role': 'CONTACT', 'email': 'rpurvis@utmck.edu'}], 'facility': 'University of Tennessee Medical Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'centralContacts': [{'name': 'Jill M Maples, PhD', 'role': 'CONTACT', 'email': 'jmaples1@utmck.edu', 'phone': '865-305-9367'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'We anticipate publishing the study protocol within the next 2 years', 'ipdSharing': 'YES', 'description': 'Reasonable requests will be considered on a case-by-case basis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee Graduate School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}