[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610188":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":43,"locations":53,"responsibleParty":72,"collaborators":76,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":34,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":56,"whyStopped":34,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Duke University","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Aim 2A: Glucose-stimulated insulin secretion with and without GLP-1 receptor blockade","PLACEBO_COMPARATOR","Aim 2A: Each subject will have a 5 hr experiment with sequential hyperglycemic clamps separated by a 90-minute washout. Blood glucose will be increased with an intravenous (IV) infusion of 20% dextrose and maintained stable at a level of 2.5-3.0 mM above fasting glucose for 90 minutes. Following the washout, a second, identical hyperglycemic clamp will be performed. Subjects will receive either saline or exendin-9 (600 pmol\u002Fkg\u002Fmin) during the clamps; in 10 subjects the saline\u002Fclamp will be first and in 10 subjects the exendin-9\u002Fclamp will be first; the orders will be assigned randomly.\n\nIntervention: The interventions here are the experimental hyperglycemia with and without exendin-9",[13],"Drug: Exendin-9 is a 30 amino acid peptide that is an established competitive antagonist of the GLP-1 receptor. Subjects will receive exendin-9 by intravenous infusion at a rate of 600 pmol\u002Fkg\u002Fmin",{"label":15,"type":16,"description":17,"interventionNames":18},"Glucose stimulated insulin secretion with or without GLP-1 receptor blockade and insulin resistance","ACTIVE_COMPARATOR","Aim 2A: Subjects will be treated with 6 mg dexamethasone once daily for 7 days to induce insulin resistance before repeating the 5 hr glucose clamp study. The infusion of glucose with saline and exendin-9 will be performed identically to the first study.\n\nIntervention: The intervention in this arm is the induction of insulin resistance with dexamethasone treatment.",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"Aim 2B: Glucose stimulated insulin secretion and insulin sensitivity","Aim 2B: Each subject will have a 3-hour experiment with a 90-minute hyperglycemic clamp at a level of 2.5-3.0 mM above fasting glucose followed by a 60 minute hyperinsulinemic (80 units\u002Fmeter2 Body Surface Area\u002Fminute), euglycemic clamp.",[23],"Drug: Dexamethasone",{"label":25,"type":16,"description":26,"interventionNames":27},"Aim 2B: Glucose stimulated insulin secretion with GLP-1 receptor blockade and insulin sensitivity","Aim 2B: Subjects will have an identical hyperglycemic clamp but with infusion of exendin-9 (600 pmol\u002Fkg\u002Fmin). Exendin-9 infusion will be stopped before the following hyperinsulinemic clamp that will be conducted identically to the control arm. Allocation of subjects in Aim 2B to the study with and without exendin-9 will be randomized.\n\nIntervention: The intervention in this study is the administration of exendin-9 during experimental hyperglycemia.",[13],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Exendin-9 is a 30 amino acid peptide that is an established competitive antagonist of the GLP-1 receptor. Subjects will receive exendin-9 by intravenous infusion at a rate of 600 pmol\u002Fkg\u002Fmin","Subjects in Aim 2A will receive exendin-9 on both experimental days and dexamethasone for one week before their second experimental day.\n\nSubjects in Aim 2B will receive exendin-9 on one of their two experimental days.",[9,25,15],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Dexamethasone","Dexamethasone 6 mg daily",[20],[40],{"name":41,"affiliation":5,"role":42},"David D'Alessio, MD","PRINCIPAL_INVESTIGATOR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":34,"email":48},"Johanna Johnson, MS","CONTACT","919-660-6766","johanna.johnson@duke.edu",{"name":50,"role":46,"phone":51,"phoneExt":34,"email":52},"Alyssa Sudnick, MS","919-660-6769","alyssa.sudnick@duke.edu",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Duke Center for Living","RECRUITING","Durham","North Carolina","27705","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-78.89862,35.99403,{"lat":66,"lon":65},[69,70,71],{"name":45,"role":46,"phone":47,"phoneExt":34,"email":48},{"name":50,"role":46,"phone":51,"phoneExt":34,"email":52},{"name":41,"role":42,"phone":34,"phoneExt":34,"email":34},{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","David D'Alessio, M.D.","Professor of Medicine Duke University, Director Division of Endocrinology",[77],{"name":78,"class":79},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100610188","phase-1-role-of-alpha-to-beta-cell-communication-to-adapt-insulin-secretion-to-insulin-resistance-100610188",false,"NCT07224334","Role of Alpha-to-beta Cell Communication to Adapt Insulin Secretion to Insulin Resistance.","Alpha to Beta Cell Communication in Health and Disease","UPGRADE","Aim 2A: Inclusion Criteria:\n\n* Age 18-45\n* Body Mass Index (BMI) \\\u003C 27.0\n* Fasting plasma glucose of ≤ 95 mg\u002FdL or HbA1c value ≤ 5.8% as measured at screening visit\n\nExclusion Criteria:\n\n* Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental health disorders\n* Personal history of diabetes or pancreatitis\n* Personal history of cardiac, gastrointestinal, renal or liver disease\n* Immediate family history of diabetes\n* Renal insufficiency (eGFR \\\u003C 60 mL\u002Fkg\u002Fmin)\n* Anemia (hematocrit \\\u003C 34%) as measured at screening visit\n* Pregnant females\n* Poor vein access\n* Consumption of daily medications that alter glucose metabolism of GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)\n* Apparent sensitivity to the study peptide as determined by the skin test\n\nAim 2B: Inclusion Criteria:\n\n* Age 35-60\n* Body Mass Index (BMI) ≥ 27.0\n* Fasting plasma glucose of \\\u003C 126 mg\u002FdL or HbA1c value \\\u003C 6.5% as measured at screening visit\n\nExclusion Criteria:\n\n* Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental health disorders\n* Personal history of diabetes or pancreatitis\n* Personal history of cardiac, gastrointestinal, renal or liver disease\n* Immediate family history of diabetes\n* Renal insufficiency (eGFR \\\u003C 60 mL\u002Fkg\u002Fmin)\n* AST and\u002For ALT levels \\> 3x the upper limit of the normal range\n* Anemia (hematocrit \\\u003C 34%) as measured at screening visit\n* Pregnant females\n* Poor vein access\n* Consumption of daily medications that alter glucose metabolism of GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)\n* Apparent sensitivity to the study peptide as determined by the skin test",true,"ALL","18 Years","60 Years",{"count":93,"type":94},30,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","Glucagon secretion from α-cells has long been viewed as primarily a counterregulatory mechanism - e.g. an agent with a role to prevent blood sugar from decreasing to levels that compromise function. Our group, along with other researchers, have begun to identify a much more complex role for α-cells, raising questions about when and how glucagon may influence blood glucose levels. This proposal looks to detail proglucagon peptide secretion from α-cells and the impact this has on β-cell function and glucose tolerance, in preclinical studies of human islets and translational studies in human subjects.\n\nThis protocol registration describes Aim 2 from this NIH grant which involves 2 study populations and separate protocols but addresses a common question. Aim 3 in the grant is focused on a separate hypothesis and will be conducted and published separately from Aim 2.",[100],"Diabetes (DM)",[102,103,104,105],"insulin secretion","insulin sensitivity","GLP-1","alpha- to beta-cell communication","2026-02-03",{"date":108,"type":109},"2026-02-05","ACTUAL",{"date":111,"type":109},"2025-12-30",{"date":113,"type":94},"2027-12",{"name":74,"class":6},1]