[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527809":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":33,"responsibleParty":49,"collaborators":51,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":18,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":35,"whyStopped":18,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Steno Diabetes Center Copenhagen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Time-restricted eating","EXPERIMENTAL","TRE group for 1 year: The intervention consists of a 3-month (12 weeks) strict TRE period, where participants follow the same eating window each day with minimal support, followed by a 9-month (40 weeks) period of individually adjusted TRE according to their experiences.",[13],"Other: Time restricted eating",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Control group for 1 year: Participants will be instructed to continue their habitual lifestyle during the study and they will follow standard care with regular visits at the SDCC clinic 3-4 times\u002Fyear.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Time restricted eating","3 months (12 weeks) strict TRE intervention: Participants will be instructed to reduce their eating window by minimum 3 hours compared to habitual eating, with an eating window below 10 hours. The timing of the eating window is self-selected but should be placed between 6 am and 8 pm. Diet during the eating window is ad libitum with no further dietary restrictions.\n\n9 months (40 weeks) individually adjusted TRE intervention: An individual plan will be made based on participants' experiences during the strict TRE. Different choices of individual adjustment and support will be provided, including 1) eating window adjustments and the possibility of 'days off', 2) provision of a list of allowed calorie and caffeine free beverages that can be consumed outside the window, 3) continued opportunity to participate in peer-support group meetings, 4) extra phone calls with a project worker to discuss challenges or strategies to continue with TRE etc., and 5) further involvement of relatives.",[9],[25],{"name":26,"affiliation":5,"role":27},"Jonas S Quist, PhD","PRINCIPAL_INVESTIGATOR",[29],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","+45 26176064","jonas.salling.quist@regionh.dk",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":37,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Herlev","Denmark","2730","DK",{"type":41,"coordinates":42},"Point",[43,44],12.43998,55.72366,{"lat":44,"lon":43},[47],{"name":26,"role":30,"phone":48,"phoneExt":18,"email":32},"+4526176064",{"type":50,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[52,54,56,58],{"name":53,"class":6},"University of Leeds",{"name":55,"class":6},"Salk Institute for Biological Studies",{"name":57,"class":6},"University of Copenhagen",{"name":59,"class":6},"Glostrup University Hospital, Copenhagen","100527809","restricted-eating-time-in-the-treatment-of-type-2-diabetes-100527809",false,"NCT06152588","Restricted Eating Time in the Treatment of Type 2 Diabetes","Restricted Eating Time in the Treatment of Type 2 Diabetes - the RESET2 Trial.","RESET2","Inclusion Criteria:\n\n* Age: ≥18 years\n* Overweight or obesity (BMI ≥25 kg\u002Fm2)\n* T2D with HbA1c\\>53 mmol\u002Fmol\n* Habitual eating window ≥12 h\u002Fday (incl. foods\u002Fsnacks and energy-containing beverages)\n\nExclusion Criteria:\n\n* Bariatric surgery or planned bariatric surgery within study duration\n* Use of fast acting insulin and combination insulin products\n* Habitual CGM use\n* A wish to adhere to Ramadan\n* For women: current\u002Fplanned pregnancy or lactation\n* Alcohol or drug abuse (judged by investigator) or treatment with disulfiram\n* Severe hypoglycaemia within last year (Severe hypoglycaemia, as defined by the American Diabetes Association (ADA), denotes severe cognitive impairment requiring external assistance for recovery)\n* Inability to understand written and oral information in Danish\n* Unable or unwilling to adhere to TRE; for instance, due to competing medical conditions.\n* Medical condition which, based on investigators assessment, challenges participation including but not limited to severe heart, vascular or lung disease, cancer, chemotherapy, psychiatric, gastrointestinal, rheumatic, or endocrine diseases etc.\n* Concomitant participation in other intervention study\n* Inability to perform neuropsychological tests (e.g., severe vision and hearing impairment that can-not be improved with aids such as glasses and hearing aids, or language barrier.)\n\nExclusion criteria for the sub-study:\n\n* Magnetic resonance imaging (MRI) contraindications based on the MR department's exclusion criteria including pacemaker or other implanted electronic devices, implanted metal objects not compatible to MRI scanning and severe claustrophobia\n* Participants who do not wish to be informed about accidental findings by MR.","ALL","18 Years",{"count":71,"type":72},160,"ESTIMATED","INTERVENTIONAL",[75],"NA","The overall aim of the present study is to investigate the effectiveness of implementing a 1-year time-restricted eating (TRE)-based intervention on glycaemic control, body weight and composition, cardiometabolic risk factors, and behaviour in individuals with overweight\u002Fobesity and type 2 diabetes (T2D).",[78],"Type 2 Diabetes",[9,78,80,81,82,83],"Obesity","Overweight","Fasting","Circadian rhythm","2025-05-13",{"date":86,"type":87},"2025-05-16","ACTUAL",{"date":89,"type":87},"2024-03-21",{"date":91,"type":72},"2026-05-01",{"name":5,"class":6},1]