Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-04-12 @ 9:05 PM
Study NCT ID:
NCT02763267
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2016-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Pregnancy Regulation of Insulin and Glucose
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': 'D005951', 'term': 'Glucose Tolerance Test'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, urine, DNA, plasma, serum. With subject consent: maternal cord blood, urine, DNA, fetal cord blood, neonatal DNA, placental tissue, RNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-07', 'studyFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2016-05-04', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin secretory response', 'timeFrame': '1st trimester (gestational weeks 4-14)', 'description': 'Insulin secretory response to a glucose load (insulinogenic index), adjusted for differences in insulin resistance, in pregnant women in the 1st trimester will be compared to the insulin secretory response in non-pregnant women'}], 'secondaryOutcomes': [{'measure': 'Insulin secretory response', 'timeFrame': 'Mid-pregnancy (gestational weeks 24-28)', 'description': 'Insulin secretory response to a glucose load (insulinogenic index), adjusted for differences in insulin resistance, in pregnant women at 24-28 weeks gestation will be compared to the insulin secretory response in non-pregnant women'}, {'measure': 'Change in insulin secretory response', 'timeFrame': '1st trimester to 24-28 weeks gestation', 'description': 'Change in insulin secretory response to a glucose load (insulinogenic index) between 1st trimester and 24 to 28 weeks gestation, adjusted for changes in insulin resistance, in pregnant women who do and do not develop GDM'}, {'measure': 'Change in insulin secretory response', 'timeFrame': '1st trimester to postpartum (up to 12 weeks post-partum or up to 50 weeks after the first trimester visit, whichever comes first)', 'description': 'Change in insulin secretory response to a glucose load (insulinogenic index) between 1st trimester and postpartum, adjusted for changes in insulin resistance, in pregnant women who do and do not develop GDM'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insulin sensitivity', 'Insulin secretion', 'Pregnancy', 'Placental proteins'], 'conditions': ['Gestational Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '37097924', 'type': 'DERIVED', 'citation': 'Rosenberg EA, Seely EW, James K, Soffer MD, Nelson S, Nicklas JM, Powe CE. Carbohydrate Intake and Oral Glucose Tolerance Test Results in the Postpartum Period. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1007-e1012. doi: 10.1210/clinem/dgad234.'}]}, 'descriptionModule': {'briefSummary': 'It is unknown whether beta cell dysfunction and insulin resistance in Gestational Diabetes Mellitus (GDM) is representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the result of an imbalance of a placental hormones. Undiscovered placental factors which vary between pregnancies likely contribute to the pathogenesis of GDM. To elucidate the pathophysiology underlying GDM, the investigators will attempt to discover these factors and characterize pregnancy-associated changes in insulin secretion and sensitivity in women with and without GDM.', 'detailedDescription': 'Gestational diabetes mellitus (GDM) complicates 3-7% of pregnancies in the United States and is associated with perinatal morbidity and a high risk of future maternal type 2 diabetes. Current prevention and treatment of GDM relies on techniques developed in the type 2 diabetes population, without regard to unique physiology in pregnancy. GDM occurs in the setting of profound pregnancy changes in glucose metabolism: late pregnancy is normally characterized by marked insulin resistance. In order to maintain normal glucose levels and avoid GDM, pancreatic beta cells must augment insulin secretion to compensate. Women with GDM have inadequate beta-cell compensation for pregnancy-induced insulin resistance, resulting in hyperglycemia. It is unknown whether beta cell dysfunction and insulin resistance in GDM is representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the result of an imbalance of a placental hormones. Undiscovered placental factors which vary between pregnancies likely contribute to the pathogenesis of GDM. Discovery of these factors and elucidation of the pathophysiology underlying GDM will allow for the development better GDM-specific prevention and treatment strategies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '150 Pregnant Women with history of GDM or at risk for diabetes mellitus and 200 Nonpregnant Women with history of GDM', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women, age 18-44, non-pregnant OR in the 1st trimester of pregnancy (4-14 weeks gestation),\n* Who had GDM in a previous pregnancy\n* At risk for diabetes mellitus, as specified by the American Diabetes Association (ADA):\n* BMI ≥ 25 kg/m2 (or BMI ≥ 23 kg/m2 if Asian-American) PLUS one or more of the following:\n\n * history of giving birth to a neonate weighing \\> 9 lbs\n * first-degree family member with diabetes mellitus\n * high-risk ethnic or racial group (African-American, Hispanic, Native American, Asian-American, or Pacific Islander)\n * polycystic ovary syndrome\n * hypertension, dyslipidemia if known (HDL\\<45 and/or triglyceride level \\>250), or cardiovascular disease\n * physical inactivity\n\nExclusion Criteria:\n\n* Known pre-existing diabetes mellitus, based on patient report or medical record review\n* A1C ≥ 6.5%, detected at study visit 1\n* Use of medications known to affect glucose tolerance including corticosteroids, metformin, sulfonylureas, and others as determined by the investigators.'}, 'identificationModule': {'nctId': 'NCT02763267', 'acronym': 'SPRING', 'briefTitle': 'Study of Pregnancy Regulation of Insulin and Glucose', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Study of Pregnancy Regulation of Insulin and Glucose', 'orgStudyIdInfo': {'id': '2015P002447'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant Women', 'description': 'Pregnant women with history of GDM or at risk for diabetes mellitus will enter study during first trimester (4-14 weeks) and receive an oral glucose tolerance test (OGTT) at baseline, mid-pregnancy, and at delivery.', 'interventionNames': ['Other: Oral glucose tolerance test']}, {'label': 'Nonpregnant Women', 'description': 'Nonpregnant women with a history of GDM will undergo an OGTT at baseline.', 'interventionNames': ['Other: Oral glucose tolerance test']}], 'interventions': [{'name': 'Oral glucose tolerance test', 'type': 'OTHER', 'otherNames': ['OGTT'], 'description': '75 gram oral glucose tolerance test (fasting) at: Visit 1 (pregnant \\[4-14 weeks gestation\\] and nonpregnant women); Visit 2 (pregnant subjects only at 24-28 weeks gestation); Visit 3 (pregnant subjects only at 6-12 weeks postpartum)', 'armGroupLabels': ['Nonpregnant Women', 'Pregnant Women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Ravi I Thadhani, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Director, MGH Diabetes in Pregnancy Program', 'investigatorFullName': 'Camille Elise Powe,M.D.', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}