[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612609":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":42,"locations":51,"responsibleParty":66,"collaborators":69,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":12,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":107,"whyStopped":12,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of Copenhagen","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Baseline Characterization","NO_INTERVENTION","All participants (N=80) undergo extensive baseline characterization over three study visits. This includes assessments of insulin sensitivity, glucose tolerance, metabolic and physiological phenotyping, habitual physical activity, and dietary intake. No intervention is applied during this phase; the purpose is to establish baseline measures and characterize individual variation in insulin resistance and metabolic profiles.\n\nParticipants complete detailed clinical, physiological, and behavioral assessments without any experimental manipulation. This includes:\n\n* Measurement of insulin action and glucose tolerance\n* Dietary and physical activity profiling\n* Collection of biospecimens for molecular analyses",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Lifestyle Interventions","EXPERIMENTAL","A subset of 40 participants are randomized into one of two experimental interventions following baseline assessment:\n\n* 14 days of reduced physical activity (\\\u003C1,500 steps\u002Fday), or\n* 3 days of a hypercaloric high-fat diet\n\nThe aim is to evaluate how short-term lifestyle stressors affect insulin sensitivity and related molecular markers. Assessments from visits 4 and 5 are compared to baseline to determine within-subject changes.\n\nIntervention Names:\n\n1. Reduced Physical Activity\n\n   \\- Participants limit daily steps to \\\u003C1,500 for 14 days\n2. High-Fat Diet\n\n   * Participants consume a hypercaloric, high-fat diet for 3 days\n\nDescription of Intervention:\n\nParticipants undergo one of the two lifestyle interventions with strict monitoring and support. Selected baseline tests are repeated post-intervention to evaluate metabolic and molecular responses.",[18,19],"Behavioral: Physical Inactivity","Behavioral: Hypercaloric High-Fat Diet",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Physical Inactivity","Participants assigned to the physical inactivity intervention will reduce their daily physical activity to fewer than 1,500 steps per day for 14 consecutive days. This strict limitation significantly decreases overall movement and muscle activity, mimicking a sedentary lifestyle. The aim is to assess the short-term effects of reduced physical activity on insulin sensitivity and related metabolic processes. Compliance will be monitored using activity trackers and daily logs. Baseline metabolic and physiological assessments will be repeated after the intervention to evaluate changes.",[14],[27],"Reduced Activity",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Hypercaloric High-Fat Diet","Participants assigned to the high-fat diet intervention will consume a hypercaloric diet rich in fat for 3 consecutive days. The diet is designed to significantly increase caloric intake and fat consumption beyond habitual levels to induce short-term metabolic stress. This intervention aims to assess how a brief period of high-fat overfeeding affects insulin sensitivity and related molecular pathways. Participants' dietary intake will be carefully controlled and monitored to ensure adherence. Baseline metabolic and physiological assessments will be repeated after the intervention to evaluate changes.",[14],[33],"Overeating",[35,38,40],{"name":36,"affiliation":5,"role":37},"Jørgen F.P. Wojtaszewski, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":37},"Ylva Hellsten, Ph.D.",{"name":41,"affiliation":5,"role":37},"Henriette Pilegaard, Ph.D.",[43,47],{"name":36,"role":44,"phone":45,"phoneExt":12,"email":46},"CONTACT","+45 28751625","jw@nexs.ku.dk",{"name":48,"role":44,"phone":49,"phoneExt":12,"email":50},"Kate A Wickham, Ph.D.","+45 30638013","kawi@nexs.ku.dk",[52],{"facility":53,"status":12,"city":54,"state":12,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"August Krogh Building","Copenhagen","2100","Denmark","DK",{"type":59,"coordinates":60},"Point",[61,62],12.56553,55.67594,{"lat":62,"lon":61},[65],{"name":48,"role":44,"phone":49,"phoneExt":12,"email":50},{"type":37,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Jorgen FP Wojtaszewski","Professor",[70,72,74],{"name":71,"class":6},"University of Sydney",{"name":73,"class":6},"Queen Mary University of London",{"name":75,"class":76},"Novo Nordisk A\u002FS","INDUSTRY","100612609","defining-the-human-insulin-resistance-molecular-network-signature-100612609",false,"NCT07255807","Defining the Human Insulin Resistance Molecular Network; SIGNATURE","sIgnatuRe: Defining the Human Insulin Resistance Molecular Network","SIGNATURE","Inclusion Criteria:\n\n* Age: 25-55 years\n* Body Mass Index (BMI): 18-30 kg\u002Fm²\n* Healthy (no diagnosed chronic diseases)\n* Able and willing to comply with study procedures\n\nExclusion Criteria:\n\n* Smoking or nicotine use, current or within the past 5 years\n* Alcohol intake exceeding 10 units per week\n* Hemoglobin A1c (HbA1c) \\> 48 mmol\u002Fmol (indicative of diabetes or prediabetes)\n* Chronic diseases (e.g., cardiovascular disease, diabetes, etc.)\n* Chronic medication use, including hormonal treatments\n* High physical activity levels (more than 3 hours per week of moderate to vigorous exercise)\n* Pregnancy or within 3 months postpartum\n* Breastfeeding or within 3 months of cessation\n* Abnormal routine blood markers (as defined in lab screening)\n* Blood donation within the past 2 months",true,"ALL","25 Years","55 Years",{"count":90,"type":91},80,"ESTIMATED","INTERVENTIONAL",[94],"NA","The goal of this intervention study is to learn more about what causes insulin resistance in otherwise healthy adults, and how short-term changes in physical activity or diet may influence it. The study includes healthy male and female participants aged 25 to 55 years, who meet specific health criteria.\n\nThe main questions it aims to answer are:\n\nDoes the cause of insulin resistance vary between individuals due to their genes and lifestyle?\n\nCan the investigators identify different types (sub-phenotypes) of insulin resistance at the molecular level?\n\nResearchers will compare groups who either reduce their physical activity for 14 days or consume a high-fat diet for 3 days, to see how these changes affect insulin sensitivity and related biological markers.\n\nParticipants will:\n\n* Complete a health screening and be assessed for eligibility\n* Undergo baseline testing to measure insulin sensitivity, physical activity, diet, and metabolic health\n* Be randomly assigned to one of two short-term interventions (14 days of reduced physical activity, or 3 days of a high-fat, high-calorie diet)\n* Repeat selected tests after the intervention to assess changes\n\nThis study will help researchers better understand how lifestyle and biology interact in the development of insulin resistance, even in people who are otherwise healthy.",[97,98],"Metabolic Health","Insulin Sensitivity\u002FResistance",[100,97,101,14,23,102,103,104,105,106],"Insulin Resistance","Glucose Metabolism","High-Fat Diet","Molecular Mechanisms","Insulin Sensitivity","Metabolic Phenotyping","Human Intervention Study","NOT_YET_RECRUITING","2025-11-20",{"date":110,"type":111},"2025-12-01","ACTUAL",{"date":110,"type":91},{"date":114,"type":91},"2038-06-30",{"name":5,"class":6},1]