Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-29 @ 11:38 AM
Study NCT ID:
NCT04394806
Status:
RECRUITING
Last Update Posted:
2024-10-04
First Post:
2020-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, plasma, cord blood, cord and placental tissue,'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-05-14', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Newborn Fat Mass', 'timeFrame': '7-14 days after birth', 'description': 'Newborn fat mass measured by air displacement plethysmography (PeaPod)'}], 'secondaryOutcomes': [{'measure': 'Newborn Intrahepatic Fat', 'timeFrame': '7-14 days after birth', 'description': 'Newborn intrahepatic fat measured by Magnetic Resonance Spectroscopy (MRS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Triglycerides', 'Glucose', 'Adiposity', 'Air displacement plethysmography', 'Continuous glucose monitoring'], 'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '29931812', 'type': 'BACKGROUND', 'citation': 'Barbour LA, Farabi SS, Friedman JE, Hirsch NM, Reece MS, Van Pelt RE, Hernandez TL. Postprandial Triglycerides Predict Newborn Fat More Strongly than Glucose in Women with Obesity in Early Pregnancy. Obesity (Silver Spring). 2018 Aug;26(8):1347-1356. doi: 10.1002/oby.22246. Epub 2018 Jun 22.'}]}, 'descriptionModule': {'briefSummary': 'This study plans to learn more about how triglyceride levels in pregnancy affect newborn fat mass. Obesity in pregnancy, in the absence of gestational diabetes, is now the most common cause of large-for-gestational-age infants and increased newborn fat mass. Previous data supports the idea that maternal triglycerides, not glucose, are the strongest predictor of both total newborn fat mass and liver fat. In this study, mothers will monitor triglyceride and glucose levels at specific points in pregnancy using point-of-care meters at home. Two weeks after birth, infants will have total fat measured by air-displacement plethysmography (PEAPOD) and liver fat measures by Magnetic Resonance Spectroscopy (MRS). The central hypothesis is that in obesity, fasting triglycerides and postprandial triglycerides will predict newborn fat mass in a free-living environment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '39 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Overweight and obese pregnant women between the ages of 20-39 years old, who are receiving care at a University of Colorado Health Facility.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women less than 16 weeks gestational age\n* Between the ages of 21-39 years\n* Pre-pregnancy BMI 28-39 kg/m2\n\nExclusion Criteria\n\n* Pre-gestational diabetes or prediabetes\n* History of gestational diabetes\n* History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension \\<34wks\n* Tobacco or illicit substance use\n* Chronic steroid use'}, 'identificationModule': {'nctId': 'NCT04394806', 'briefTitle': 'The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy', 'orgStudyIdInfo': {'id': '20-0706'}}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Dunn, MS, RDN', 'role': 'CONTACT', 'email': 'Emily.2.Dunn@cuanschutz.edu', 'phone': '303-724-0320'}, {'name': 'Linda A Barbour, MD, MSPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Teri L Hernandez, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado/Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Emily Z Dunn, MS, RDN', 'role': 'CONTACT', 'email': 'Emily.2.Dunn@cuanschutz.edu', 'phone': '303-724-0320'}, {'name': 'Nicole Hirsch, MS', 'role': 'CONTACT', 'email': 'Nicole.Hirsch@cuanschutz.edu', 'phone': '303-724-0572'}], 'overallOfficials': [{'name': 'Linda A Barbour, MD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Teri L Hernandez, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}