[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534544":3},{"organization":4,"outcomesModule":7,"designInfo":105,"detailedDescription":113,"studyPopulation":35,"armGroups":114,"interventions":125,"overallOfficials":129,"centralContacts":134,"locations":143,"responsibleParty":161,"collaborators":164,"id":170,"slug":35,"hasResults":171,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":35,"eligibilityCriteria":175,"healthyVolunteers":176,"sex":177,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":35,"studyType":183,"phases":184,"briefSummary":186,"conditions":187,"keywords":35,"overallStatus":146,"whyStopped":35,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"The change in food intake at an ad libitum meal during GLP-1 infusion","Food intake will be evaluated as ingested food in grams","From baseline (week 0) to follow-up (week 2).",[14,18,21,24,26,29],{"measure":15,"description":16,"timeFrame":17},"The change in preference for unhealthy food ( combined score for high fat food, savory food, and sweet food).","Evaluated by visual food stimuli combined with eye tracking","From baseline (week 0) to follow-up (week 2)",{"measure":19,"description":20,"timeFrame":17},"The change in subjective experience of severity and type of food cravings","Evaluated by the Control of Eating Questionnaire.",{"measure":22,"description":23,"timeFrame":17},"The change in subjective feeling of satiety","Evaluated by a visual analogue scale",{"measure":25,"description":23,"timeFrame":17},"The change in subjective felling of hunger",{"measure":27,"description":28,"timeFrame":17},"The change in satiety composite appetite score","Calculated from visual analog scales",{"measure":30,"description":31,"timeFrame":30},"Sub study","Comparison between Ad libitum meal +\u002F- GLP-1 infusion on primary and secondary outcomes of the primary study.",[33,36,39,42,44,47,50,52,55,58,60,62,65,67,70,72,74,76,79,81,83,85,88,90,93,96,99,102],{"measure":34,"description":35,"timeFrame":17},"Change in secretion of gut hormones (GLP-1, GIP, PYY, ghrelin, CCK)",null,{"measure":37,"description":38,"timeFrame":17},"Change in gastric emptying rate","Measured by surrogate marker paracetamol",{"measure":40,"description":41,"timeFrame":17},"Change in body composition (body weight, body mass index, lean mass, fat mass)","Based on DXA scans",{"measure":43,"description":35,"timeFrame":17},"Change in physical fitness (maximal aerobic capacity, one repetition max)",{"measure":45,"description":46,"timeFrame":17},"Change in plasma glucose during ad libitum meal","AUC (mol\u002Fhour)",{"measure":48,"description":49,"timeFrame":17},"Change in plasma insulin during ad libitum meal","AUC (mol\u002Fh)",{"measure":51,"description":46,"timeFrame":17},"Change in plasma c-peptide during ad libitum meal",{"measure":53,"description":54,"timeFrame":17},"Change in glucagon supression during ad libitum meal","The % glucagon supression at time 0-30min, 0-60min and 0-120min",{"measure":56,"description":57,"timeFrame":17},"Change in plasma insulin\u002Fglucagon ratio during ad libitum meal","Insulin\u002Fglucagon at time=30, 60 and 120",{"measure":59,"description":46,"timeFrame":17},"Change in plasma glucose during mixed meal tolerance test",{"measure":61,"description":46,"timeFrame":17},"Change in plasma insulin during mixed meal tolerance test",{"measure":63,"description":64,"timeFrame":17},"Change in insulin\u002Fc-peptide ratio during mixed meal tolerance test","Insulin\u002Fglucagon at time 30min, 60min, 120min and 180",{"measure":66,"description":46,"timeFrame":17},"Change in plasma c-peptide during mixed meal tolerance test",{"measure":68,"description":69,"timeFrame":17},"Change in glucagon supression during mixed meal tolerance test","The % glucagon supression at time 0-30min, 0-60min, 0-120min and 0-180",{"measure":71,"description":64,"timeFrame":17},"Change in plasma insulin\u002Fglucagon ratio during mixed meal tolerance test",{"measure":73,"description":35,"timeFrame":17},"Change in plasma concentration of cytokines (IL-1Ra, IL-6, IL-10, CRP, TNF-α, GDF-15)",{"measure":75,"description":35,"timeFrame":17},"Change in plasma concentration of adipokines (leptin and adiponectin)",{"measure":77,"description":78,"timeFrame":17},"Change in glycaemic variability","CV% derived from free-living continuous glucose monitoring",{"measure":77,"description":80,"timeFrame":17},"SD derived from free-living continuous glucose monitoring",{"measure":77,"description":82,"timeFrame":17},"Mean glucose derived from free-living continuous glucose monitoring",{"measure":77,"description":84,"timeFrame":17},"Time in range derived from free-living continuous glucose monitoring",{"measure":86,"description":87,"timeFrame":17},"Change in physical and mental well-being","Based on scores from WHO5, HAM-DS-S, and GAD-10 questionnaires",{"measure":86,"description":89,"timeFrame":17},"Based on scores from WHO5 questionnaires",{"measure":91,"description":92,"timeFrame":17},"Change in symptoms of depression","Based on scores from HAM-D6-S questionnaires",{"measure":94,"description":95,"timeFrame":17},"Change in symptoms of anxiety","Based on scores from GAD-10 questionnaires",{"measure":97,"description":98,"timeFrame":17},"Change in sleep Quality","Based on scores from Pittsburgh Sleep Quality Index",{"measure":100,"description":101,"timeFrame":17},"Change in plasma peptides","Evaluated by peptidomics",{"measure":103,"description":104,"timeFrame":17},"Change in plasma metabolites","Evaluated by metabolomics",{"allocation":106,"interventionModel":107,"interventionModelDescription":35,"primaryPurpose":108,"observationalModel":35,"timePerspective":35,"maskingInfo":109},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":110,"maskingDescription":35,"whoMasked":111},"SINGLE",[112],"INVESTIGATOR","To contextualize the changes in ad libitum food intake driven by two weeks of physical inactivity, a sub-study will assess the effect of GLP-1 infusion on ad libitum food intake compared with a saline control in 20 participants included based on same eligibility criteria as in the main study. The estimated GLP-1 induced change in ad libitum food intake will be descriptively compared to the estimated GLP-1 + inactivity induced change in ad libitum food intake (main-study) to provide context for any attenuation in appetite suppression observed in the main-study. Outcomes related to subjective appetite measures (hunger, satiety, and food preference) will also be assessed in this way.\n\nThe primary hypothesis is that GLP-1 infusion will suppress appetite and reduce ad libitum food intake compared with saline control. The secondary hypothesis is that GLP-1 infusion will diminish subjective feelings of hunger and increase satiety.",[115,121],{"label":116,"type":117,"description":118,"interventionNames":119},"Inactivity","EXPERIMENTAL","Inactivity will be implemented as cessation of active commuting and all other structured exercise. Furthermore, steps will be reduced to a maximum of 1500 steps\u002Fday.",[120],"Behavioral: Inactivity",{"label":122,"type":123,"description":124,"interventionNames":35},"Control","NO_INTERVENTION","Participants will be instructed to maintain habitual physical activity and dietary habits.",[126],{"type":127,"name":116,"description":118,"armGroupLabels":128,"otherNames":35},"BEHAVIORAL",[116],[130],{"name":131,"affiliation":132,"role":133},"Grit Elster Legård, MD, PhD","Centre for Physical Activity Research, Rigshospitalet","PRINCIPAL_INVESTIGATOR",[135,140],{"name":136,"role":137,"phone":138,"phoneExt":35,"email":139},"Inge Holm","CONTACT","+45 35 45 76 41","inge.holm@regionh.dk",{"name":141,"role":137,"phone":138,"phoneExt":35,"email":142},"Bente K Pedersen, Dr Med","Bente.Klarlund.Pedersen@regionh.dk",[144],{"facility":145,"status":146,"city":147,"state":35,"zip":35,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":155,"contacts":156},"Copenhagen University Hospital","RECRUITING","Copenhagen","Denmark","DK",{"type":151,"coordinates":152},"Point",[153,154],12.56553,55.67594,{"lat":154,"lon":153},[157],{"name":158,"role":137,"phone":159,"phoneExt":35,"email":160},"Grit E Legård","+45 35457641","grit.elster.legaard@regionh.dk",{"type":133,"investigatorFullName":162,"investigatorTitle":163,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Grit Elster Legård","Primary Investigator",[165,168],{"name":166,"class":167},"Novo Nordisk A\u002FS","INDUSTRY",{"name":169,"class":167},"TrygFonden, Denmark","100534544",false,"NCT06240208","Physical Inactivity and Appetite Regulation","The Effects of Inactivity on GLP-1 Stimulated Appetite Regulation in Healthy Normal Weight Males: A Randomised, Parallel Group Study","Inclusion Criteria:\n\n1. Male\n2. Age ≥ 40 years and ≤ 55 years\n3. Body mass index (BMI) \\> 20 and \\\u003C 25 kg\u002Fm2\n4. Physical activity level should as a minimum include: Active commuting by biking a minimum of 10 km, four days per week or an equivalent amount of other physical activity four days per week.\n5. Healthy (based on self-reporting, pre-study medical examination and biochemical screening)\n6. Can adhere to two weeks of inactivity (refrain from running, cycling and all other exercise while reducing steps to max. 1500 pr. day)\n7. Caucasian\n8. No change in body weight \\> 5 kg within the last 6 months\n9. Eats breakfast and lunch daily\n10. Does not follow specific dietary restrictions\n11. No disliking of spaghetti bolognese\n12. No diagnosis of psychiatric disorder or treatment with anti-depressant or anti-psychotic medication\n13. No history of suicidal behavior or ideations.\n14. No previous surgical treatment for obesity\n15. No cardiovascular disease\n16. No rheumatologic disease\n17. No metabolic\u002Fendocrine disease\n18. No liver disease (ASAT or ALAT \\>2x upper normal range)\n19. No other chronic disease\n20. No elite sports\n21. No frequent or chronic use of medications affecting bodyweight, physical performance, or inflammation (NSAIDS, DMARDS, corticosteroids)\n22. No current infection\n23. No history of cancer\n24. No anemia (hematocrit \\\u003C33%)\n25. No smoking\n26. No participation in other research intervention studies\n\nExclusion Criteria:\n\n1. Clinical or biochemical signs of disease\n2. HbA1c \\> 39 mmol\u002Fmol\n3. Unable to allocate the needed time to fulfill the intervention\n4. Language barrier, mental incapacity, unwillingness, or inability to understand and be able to complete the interventions",true,"MALE","40 Years","55 Years",{"count":181,"type":182},40,"ESTIMATED","INTERVENTIONAL",[185],"NA","The goal of this parallel-group, two-arm, assessor-blinded, randomised clinical trial is to investigate the effects of reducing physical activity on food intake and satiety in physically active and healthy males, 40-55 years of age.\n\nThe main questions it aims to answer are:\n\n* Does physical inactivity affect GLP-1 stimulated food intake?\n* Does physical inactivity affect food preferences, satiety and other mechanisms supporting appetite regulation?\n\nParticipants will be randomised (1:1) to two weeks of either no intervention (control group) or inactivity. Inactivity will be implemented as cessation of active commuting and all other structured exercise. Furthermore, steps will be reduced to a maximum of 1500 steps\u002Fday.\n\nResearchers will compare the inactivity group to the control group to see if physical inactivity impairs appetite regulation.",[188],"Overweight","2026-03-25",{"date":191,"type":192},"2026-03-30","ACTUAL",{"date":194,"type":192},"2024-03-01",{"date":196,"type":182},"2026-12",{"name":5,"class":6},1]