[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658627":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":53,"interventions":66,"overallOfficials":83,"centralContacts":88,"locations":94,"responsibleParty":108,"collaborators":111,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":41,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":41,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":138,"whyStopped":41,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"University of Copenhagen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":41},[9,13],{"measure":10,"description":11,"timeFrame":12},"Hypothalamic response to glucose ingestion during GLP-1 receptor blockade compared with saline","Blood oxygen level-dependent (BOLD) time series are extracted from the hypothalamus and expressed relative to the BOLD signal during fasting. The hypothalamic response to glucose ingestion is defined as the relative difference between the gastric glucose condition and the isoglycemic intravenous glucose condition, pre-specified as the net area under the curve (netAUC). This outcome is reported as the difference between conditions in each group, and compared between groups.","During the MRI scan on three test days",{"measure":14,"description":11,"timeFrame":12},"Hypothalamic response to glucose ingestion during GLP-1 infusion compared with saline",[16,20,24,28,32,35,38],{"measure":17,"description":18,"timeFrame":19},"Ad libitum energy intake","Energy intake at an ad libitum meal, recorded as an objective measure of satiety, reported as the difference between conditions within each group.","After the MRI scan on four test days",{"measure":21,"description":22,"timeFrame":23},"Subjective appetite sensations","Appetite sensations rated on visual analogue scales (0-100 mm; higher scores indicate a stronger sensation), reported as the difference between conditions within each group.","Immediately before and immediately after the MRI scan on four test days",{"measure":25,"description":26,"timeFrame":27},"T2 relaxation time in the mediobasal hypothalamus","T2 relaxation time is measured in the mediobasal hypothalamus using a T2-weighted sequence previously validated for quantification of hypothalamic gliosis. Longer T2 relaxation time indicates greater gliosis.","During the MRI scan on one of four test day",{"measure":29,"description":30,"timeFrame":31},"Plasma glucose concentration","Glucose concentration (mmol\u002FL) measured in plasma at fasting baseline and at repeated time points during the MRI scan on each test day. Concentrations are reported for each group and compared between groups.","Fasting baseline and during the MRI scan on four test days",{"measure":33,"description":34,"timeFrame":31},"Plasma GLP-1 concentration","GLP-1 concentration (pmol\u002FL) measured in plasma at fasting baseline and at repeated time points during the MRI scan on each test day. Concentrations are reported for each group and compared between groups.",{"measure":36,"description":37,"timeFrame":31},"Plasma insulin concentration","Insulin concentration (pmol\u002FL) measured in plasma at fasting baseline and at repeated time points during the MRI scan on each test day. Concentrations are reported for each group and compared between groups.",{"measure":39,"description":40,"timeFrame":31},"Plasma C-peptide concentration","C-peptide concentration (pmol\u002FL) measured in plasma at fasting baseline and at repeated time points during the MRI scan on each test day. Concentrations are reported for each group and compared between groups.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"RANDOMIZED","CROSSOVER","Participants are assigned to one of two groups according to body mass index: healthy weight, or obesity, matched by age and sex. Each participant completes all four experimental conditions; randomization applies to the order of test days 2 to 4 within each participant.","BASIC_SCIENCE",{"masking":48,"maskingDescription":49,"whoMasked":50},"DOUBLE","Participants are blinded to the test conditions. The outcome assessor will be blinded to condition allocation until the analyses are complete.",[51,52],"PARTICIPANT","OUTCOMES_ASSESSOR",[54,63],{"label":55,"type":56,"description":57,"interventionNames":58},"Healthy weight","EXPERIMENTAL","Each participant completes all four experimental conditions. Gastric glucose administration is conducted on the first test day; the following three test days are performed in randomized order.",[59,60,61,62],"Other: Gastric glucose","Other: GLP-1(7-36)NH2","Other: Exendin(9-39)NH2","Other: Isoglycemic intravenous glucose infusion",{"label":64,"type":56,"description":57,"interventionNames":65},"Obesity",[59,60,61,62],[67,71,75,79],{"type":6,"name":68,"description":69,"armGroupLabels":70,"otherNames":41},"Gastric glucose","Gastric glucose administration with intravenous saline infusion.",[55,64],{"type":6,"name":72,"description":73,"armGroupLabels":74,"otherNames":41},"GLP-1(7-36)NH2","GLP-1(7-36)NH2 infusion with gastric glucose administration.",[55,64],{"type":6,"name":76,"description":77,"armGroupLabels":78,"otherNames":41},"Exendin(9-39)NH2","Exendin(9-39)NH2 infusion with gastric glucose administration.",[55,64],{"type":6,"name":80,"description":81,"armGroupLabels":82,"otherNames":41},"Isoglycemic intravenous glucose infusion","Glucose infusion with rate adjustment to replicate the individual plasma glucose excursion observed during gastric glucose administration on test day 1.",[55,64],[84],{"name":85,"affiliation":86,"role":87},"Sarah Byberg, MD, PhD","University of Copenhagen, Department of Biomedical Sciences","PRINCIPAL_INVESTIGATOR",[89],{"name":90,"role":91,"phone":92,"phoneExt":41,"email":93},"Sarah Byberg, MD","CONTACT","+45 50247452","sarah.byberg@sund.ku.dk",[95],{"facility":86,"status":41,"city":96,"state":41,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Copenhagen","2200","Denmark","DK",{"type":101,"coordinates":102},"Point",[103,104],12.56553,55.67594,{"lat":104,"lon":103},[107],{"name":85,"role":91,"phone":41,"phoneExt":41,"email":41},{"type":87,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Sarah Byberg","MD, Assistant Professor",[112],{"name":113,"class":6},"Copenhagen University Hospital, Rigshospitalet","100658627","hypothalamic-glp-1-response-in-healthy-weight-and-obesity-100658627",false,"NCT07854886","Hypothalamic GLP-1 Response in Healthy Weight and Obesity","Quantifying Hypothalamic GLP-1 Response in Healthy Weight and Obesity: A Randomized Crossover Neuroimaging Infusion Study","Inclusion Criteria:\n\nGroup 1:\n\n* Age 18-75 years\n* BMI 18.5-25 kg\u002Fm²\n* Normal glucose tolerance (Fasting glucose \\\u003C 5.6 mmol\u002FL)\n\nGroup 2:\n\n* Age and sex-matched with group 1\n* BMI≥30 kg\u002Fm²\n* Impaired glucose tolerance (Fasting glucose 5.6 - 6.9 mmol\u002FL)\n\nExclusion Criteria:\n\n* Diabetes mellitus type 1 or type 2, or fasting plasma glucose \\> 7.0 mmol\u002FL\n* Treatment with GLP-1 receptor agonists or other GLP-1-based therapies within the past three months\n* Use of medication affecting appetite, body weight, or glucose metabolism within the past three months\n* Current eating disorder (anorexia nervosa, bulimia nervosa)\n* Known serious chronic disease, including but not limited to:\n\n  * Heart disease\n  * Anemia (hemoglobin \\\u003C7.0 mmol\u002FL for women, \\\u003C8.0 mmol\u002FL for men)\n  * Renal impairment (eGFR \\\u003C60 mL\u002Fmin\u002F1.73m²)\n  * Hepatic impairment (ALT or AST \\>3 times upper limit of normal)\n* Known monogenic obesity\n* Substance abuse (current or within the past year)\n* Previous bariatric surgery\n* Contraindications to study procedures, including:\n\n  * Esophageal or nasal obstruction (e.g. tumors, strictures)\n  * Coagulopathy\n  * History of skull base trauma\n  * Esophageal varices\n  * Hiatal hernia\n  * Claustrophobia\n  * Inability to comply with MRI requirements (e.g. remaining still)\n  * Presence of non-removable magnetic objects incompatible with MRI\n  * Any other condition or circumstance that, in the opinion of the study physician, may compromise safe participation in the study.\n\nExclusion criteria for women:\n\n* Pregnancy, breastfeeding, or wish to become pregnant during the study period\n* Women of childbearing potential not using adequate contraception\n* Women using hormonal contraception (oral contraceptives, progestin- containing implants or hormonal intrauterine device.)",true,"ALL","18 Years","75 Years",{"count":126,"type":127},60,"ESTIMATED","INTERVENTIONAL",[130],"NA","The goal of this clinical trial is to learn how the gut hormone glucagon-like peptide-1 (GLP-1) helps the brain sense sugar. It includes adults with healthy weight and adults with obesity.\n\nThe main questions this trial aims to answer are:\n\nA. Does GLP-1 cause the brain's response to sugar? B. Do lower GLP-1 levels cause a weaker brain response to sugar in adults with obesity?\n\nResearchers will compare each participant's brain response across four test days. On these days, GLP-1 levels will be blocked, raised, or left unchanged. Sugar will be given either into the stomach or into a vein.\n\nParticipants will:\n\nAttend 1 screening visit Visit the clinic for 4 test days Receive sugar and get an MRI scan of their brain on each test day",[64,133,134],"Normal Weight","Glucose Intolerance",[136,137,64],"GLP-1","Hypothalamus","NOT_YET_RECRUITING","2026-10-01",{"date":141,"type":142},"2026-10-02","ACTUAL",{"date":139,"type":127},{"date":145,"type":127},"2028-09-30",{"name":5,"class":6},1]