[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465449":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":33,"responsibleParty":53,"collaborators":31,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":31,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":35,"whyStopped":31,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Medical University of Bialystok","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Semaglutide (oral)","EXPERIMENTAL","In this study, each participant will receive a regimen of oral semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, for a duration of twelve weeks. The dosage will begin at 3 mg\u002Fday for weeks 1-2, gradually increasing to 7 mg\u002Fday for weeks 3-4, 14 mg\u002Fday for weeks 5-6, 28 mg\u002Fday for weeks 7-8, and finally, to 42 mg\u002Fday for the last four weeks (weeks 9-12).",[13],"Drug: Semaglutide Pill",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Semaglutide Pill","Oral semaglutide treatment",[9],[21],"Rybelsus",[23],{"name":24,"affiliation":25,"role":26},"Lukasz Szczerbinski, MD, PhD","Clinical Research Centre, Medical University of Bialystok","PRINCIPAL_INVESTIGATOR",[28],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","+48858318150",null,"lukasz.szczerbinski@umb.edu.pl",[34],{"facility":25,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Bialystok","Podlaskie Voivodeship","15-276","Poland","PL",{"type":42,"coordinates":43},"Point",[44,45],23.16433,53.13333,{"lat":45,"lon":44},[48,50,52],{"name":24,"role":29,"phone":49,"phoneExt":31,"email":32},"+48 85 831 81 50",{"name":51,"role":26,"phone":31,"phoneExt":31,"email":31},"Adam Kretowski, MD, PhD",{"name":24,"role":26,"phone":31,"phoneExt":31,"email":31},{"type":54,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100465449","genetics-of-the-acute-response-to-oral-semaglutide-100465449",false,"NCT05340868","Genetics of the Acute Response to Oral Semaglutide","Genetics of the Acute Response to Oral Semaglutide (GAROS)","GAROS","Inclusion Criteria:\n\n* Informed consent was given before any study-related action on the subject.\n* Age: 18-65 years old\n* Body mass index (BMI) \\>30 kg\u002Fm2 or \\>27 kg\u002Fm2 when accompanied by prediabetes, diagnosed according to the criteria of the American Diabetes Association\n\nExclusion Criteria:\n\n* Patients diagnosed with a serious chronic disease, including:\n\n  * Ischemic heart disease\n  * Heart failure (NYHA class III-IV)\n  * Severe renal insufficiency (eGFR \\\u003C30 ml\u002Fmin)\n  * Severe liver diseases\n  * Inflammatory bowel disease\n  * Diabetic gastroparesis\n  * Cancer - currently or in the last five years prior to screening\n  * Chronic obstructive pulmonary disease\n  * History of mental illness, major depression or other severe mental disorders\n* Use of any medications with clinically-proven significant weight gain or loss effects\n* History of undergoing bariatric surgery or other surgery involving the stomach that could affect the absorption of the study drug (according to the investigator's opinion)\n* History of idiopathic acute pancreatitis\n* A family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid cancer\n* For women - pregnancy, breastfeeding or planning pregnancy.\n* Women of childbearing age who are not using highly effective methods of contraception\n* Known or suspected hypersensitivity to the test product",true,"ALL","18 Years","65 Years",{"count":68,"type":69},1000,"ESTIMATED","INTERVENTIONAL",[72],"NA","The study aims to investigate the genetic basis of the response to short-term (3 months) orally administered semaglutide treatment, in terms of improving metabolic parameters, including the hormonal response to a standardized meal, and changes in body composition and liver steatosis. In the study, parameters such as fasting and 2-hour glucose during OGTT, HbA1c, body fat mass, body weight, total cholesterol, HDL and LDL, triglycerides, HOMA-IR, Matsuda Index and liver steatosis will be assessed. All the patients will undergo genome-wide genotyping. Moreover, in a subset of participants, muscle and fat biopsies will be performed, before and after the treatment, and liver, muscle and pancreas fat content will be assessed using MRI.",[75,76,77],"PreDiabetes","Prediabetic State","Obesity",[79,80,81,82],"pharmacogenetics","semaglutide","prediabetes","obesity","2025-03-21",{"date":85,"type":86},"2025-03-26","ACTUAL",{"date":88,"type":86},"2022-09-01",{"date":90,"type":69},"2025-12-31",{"name":5,"class":6},1]