[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516333":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":20,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":20,"overallStatus":42,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"GLUCOSE-MGH Study","Day 1: Mixed meal tolerance test\n\nDay 3-15: 7 mg oral semaglutide, once daily\n\nDay 16: 1 dose of 7 mg oral semaglutide, Mixed meal tolerance test in the presence of semaglutide",[12,13],"Drug: oral semaglutide","Other: Mixed Meal Tolerance Test (MMTT)",[15,21],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","oral semaglutide","Semaglutide is the only oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) approved for treatment of type 2 diabetes. Participants will receive 7 mg of oral semaglutide once daily for 14 days in between Visit 1 and Visit 2.",[9],null,{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"Mixed Meal Tolerance Test (MMTT)","The MMTT is developed by the Metabolism and Nutrition Metabolic Kitchen at the MGH TCRC. The meal is a high-calorie, high-carbohydrate and moderate-to-high glycemic index challenge composed of commonly consumed breakfast food items. It provides nearly 90 grams of carbohydrates and mimics an oral glucose challenge. The participants will undergo a MMTT at Visit 1 and Visit 2.",[9],[26],{"name":27,"affiliation":28,"role":29},"Josephine Li, MD","MGH","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":20,"email":35},"Varinderpal Kaur","CONTACT","6176435419","vkaur@mgh.harvard.edu",{"name":37,"role":33,"phone":38,"phoneExt":20,"email":39},"Josephine Li","617-643-4987","jli71@mgh.harvard.edu",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-71.05977,42.35843,{"lat":52,"lon":51},[55,56],{"name":32,"role":33,"phone":34,"phoneExt":20,"email":35},{"name":27,"role":29,"phone":20,"phoneExt":20,"email":20},{"type":29,"investigatorFullName":27,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Assistant Professor of Medicine",[60],{"name":61,"class":62},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100516333","phase-4-glucose-mgh-genetic-links-understood-through-challenge-with-oral-semaglutide-exposure-at-mgh-100516333",false,"NCT06003153","GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH","GLUCOSE-MGH","Inclusion Criteria:\n\n1. Males or non-pregnant females\n2. Ages 18-65 (inclusive)\n3. Able\u002Fwilling to give consent\n4. Span the metabolic range between normal glycemia and pre-diabetes (fasting glucose of 100-125 mg\u002FdL based on chart review of existing laboratory data)\n\nExclusion Criteria:\n\n1. Currently taking medications or intending to take medications for diabetes\n2. Currently taking medications or intending to take medications that affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones\n3. Personal history of intestinal malabsorption, bariatric surgery, celiac disease, gallbladder disease, or pancreatitis\n4. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2\n5. Estimated glomerular filtration rate (eGFR) \\\u003C60 ml\u002Fmin\u002F1.73 m2 per the Modification of Diet in Renal Disease equation\n6. History of cirrhosis and\u002For aspartate aminotransferase or alanine aminotransferase more than 3x upper limit of normal\n7. Dietary restrictions preventing consumption of a MMTT\n8. Women who are pregnant, nursing, or at risk of becoming pregnant\n9. Participation in other interventional studies during the current study",true,"ALL","18 Years","65 Years",{"count":75,"type":76},125,"ESTIMATED","INTERVENTIONAL",[79],"PHASE4","The goal of this research study is to evaluate the pathophysiologic mechanisms by which genetic variation impacts response to an FDA-approved medication commonly used to treat type 2 diabetes called oral semaglutide (Rybelsus) and to characterize the physiological response to a mixed meal tolerance test (MMTT) before and after a 14-day treatment with oral semaglutide. The investigators will do this by measuring factors in the blood, such as sugars, fats, metabolites, and proteins, after eating a standardized breakfast meal at the first visit and after taking 14 doses of oral semaglutide over two weeks before the second study visit. The food (mixed meal breakfast) we will be studying is specially prepared to contain a set amount of protein, carbohydrates, and fat. The investigators hypothesize that understanding how the acute biochemical response to oral semaglutide differs by genetic variation will generate insight into drug mechanisms and type 2 diabetes pathophysiology.",[82,83,84],"Genetic Predisposition","Metabolic Diseases","Type 2 Diabetes","2026-04-03",{"date":87,"type":88},"2026-04-06","ACTUAL",{"date":90,"type":88},"2024-03-12",{"date":92,"type":76},"2027-05-31",{"name":5,"class":6},1]