[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655054":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":23,"armGroups":30,"interventions":41,"overallOfficials":47,"centralContacts":51,"locations":61,"responsibleParty":78,"collaborators":81,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":23,"eligibilityCriteria":90,"healthyVolunteers":87,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":23,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":23,"overallStatus":63,"whyStopped":23,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Mayo Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"G50","The change in glucose concentration necessary to suppress glucagon secretion rate by 50%. A measurement of α-cell function.","During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Glucagon Secretion Rate","The amount of glucagon produced over time expressed as pmol\u002Fmin. A measurement of α-cell function.",{"measure":18,"description":19,"timeFrame":12},"delta insulin secretion rate\u002Fdelta glucose","This measurement quantifies the change in insulin secretion in response to rising glucose concentrations. it is a surrogate of β-cell function. Insulin secretion rate will be calculated from C-peptide concentrations using nonparametric deconvolution and population-based measures of C-peptide kinetics.",{"measure":21,"description":22,"timeFrame":12},"β-Cell responsivity (Φ)","This index quantifies the relationship between fasting glucose and fasting insulin secretion rate. This will allow us to assess and quantify fasting β-cell function.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"NON_RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"Women With Gestational Diabetes Mellitus","EXPERIMENTAL","Pregnant participants diagnosed with gestational diabetes mellitus who complete pregnancy and postpartum metabolic study visits.",[36],"Drug: Exendin 9-39",{"label":38,"type":33,"description":39,"interventionNames":40},"Women Without Gestational Diabetes Mellitus","Pregnant participants without gestational diabetes mellitus, matched to the gestational diabetes group by parity, age, ethnicity, gestational week at diagnosis comparator timepoint, and first trimester body mass index.",[36],[42],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":23},"DRUG","Exendin 9-39","Exendin 9-39 will be administered during one postpartum study day as an intravenous infusion at 300 pmol\u002Fkg\u002Fmin for 4 hours, beginning 60 minutes before the graded glucose infusion and continuing through the end of the 180-minute glucose infusion study period",[32,38],[48],{"name":49,"affiliation":5,"role":50},"Aoife Egan, MB, BCh, PhD","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":23,"email":56},"Jeanette Laugen","CONTACT","507-255-8110","laugen.jeanette@mayo.edu",{"name":58,"role":54,"phone":59,"phoneExt":23,"email":60},"Amy Zipse","507-255-9278","zipse.amy@mayo.edu",[62],{"facility":5,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-92.4699,44.02163,{"lat":73,"lon":72},[76,77],{"name":53,"role":54,"phone":55,"phoneExt":23,"email":23},{"name":58,"role":54,"phone":59,"phoneExt":23,"email":23},{"type":50,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Aoife Egan","Principal Investigator",[82],{"name":83,"class":84},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100655054","phase-1-islet-function-in-gestational-diabetes-100655054",false,"NCT07806695","Islet Function in Gestational Diabetes","Inclusion Criteria:\n\n* Pregnant individuals with a viable singleton pregnancy who have completed second trimester gestational diabetes screening and are eligible for classification as either gestational diabetes mellitus or no gestational diabetes mellitus.\n* Participants must be willing and able to provide informed consent and complete planned pregnancy and postpartum study visits.\n\nExclusion Criteria:\n\n* Active systemic illness (e.g. chronic kidney disease, hypertension)\n* Pre-pregnancy diabetes mellitus\n* Multiple gestation, major fetal anomaly, or non-viable pregnancy on ultrasound\n* Fasting glucose ≥ 100 mg\u002FdL or HbA1c ≥ 5.7% in early pregnancy\n* One abnormal value on the 3-hour 100 g oral glucose tolerance test\n* Glucose at least 190 mg\u002FdL on glucose challenge testing without subsequent 3-hour oral glucose tolerance testing\n* Use of medication affecting glucose metabolism before pregnancy or in early pregnancy\n* Use of glucose-lowering medication (e.g. metformin, glyburide) other than insulin to treat gestational diabetes mellitus in the current pregnancy\n* History of upper gastrointestinal surgery that alters gastric emptying (e.g. bariatric surgery)\n* Hemoglobin \\\u003C than 11 g\u002FdL","FEMALE","20 Years","40 Years",{"count":95,"type":96},90,"ESTIMATED","INTERVENTIONAL",[99],"PHASE1","The purpose of this research is to understand how the function of the human pancreas changes during and after pregnancy.",[102],"Gestational Diabetes Mellitus","2026-09-04",{"date":105,"type":106},"2026-09-08","ACTUAL",{"date":108,"type":96},"2026-09",{"date":110,"type":96},"2030-12",{"name":5,"class":6},1]