[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434955":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":60,"collaborators":62,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":25,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":96,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Bergen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Energy Restricted Diet","ACTIVE_COMPARATOR","A nutritional complete formula diet for 3 months followed by an energy restricted diet for 12 months.",[13],"Other: Energy restricted diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Continuous LCHF Diet","EXPERIMENTAL","A very low-carbohydrate high-fat ketogenic diet (VLCHF) diet for 3 months, followed by a low-carbohydrate high-fat diet (LCHF) for 12 months.",[19],"Other: Low carbohydrate high fat diet",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Energy restricted diet","Nutritional complete formula diet followed by an energy restricted diet",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Low carbohydrate high fat diet","Very low-carbohydrate high-fat ketogenic diet (VLCHF) diet followed by a low-carbohydrate high-fat diet (LCHF)",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Simon N Dankel, PhD","CONTACT","+4794308637","Simon.Dankel@uib.no",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Kristin Amundsen, MSc","+4797171257","k.amundsen@uib.no",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Department of Clinical Science","RECRUITING","Bergen","Vestland","5021","Norway","NO",{"type":50,"coordinates":51},"Point",[52,53],5.32415,60.39299,{"lat":53,"lon":52},[56],{"name":57,"role":33,"phone":58,"phoneExt":25,"email":59},"Pål R Njølstad","+47 55 97 51 53","Pal.Njolstad@uib.no",{"type":61,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[63,65,67,69],{"name":64,"class":6},"Karolinska Institutet",{"name":66,"class":6},"University of Glasgow",{"name":68,"class":6},"University of Copenhagen",{"name":70,"class":6},"Technical University of Munich","100434955","dietary-strategies-for-remission-of-type-2-diabetes-100434955",false,"NCT04943926","Dietary Strategies for Remission of Type 2 Diabetes","Dietary Strategies for Remission of Type 2 Diabetes - a Randomized Controlled Trial (CARBCOUNT)","CARBCOUNT","Inclusion Criteria:\n\n* HbA1c ≥48 mmol\u002Fmol (with or without medical treatment)\n* Less than 10 years since the diagnosis of T2D\n* BMI ≥27 kg\u002Fm2 (≥25 kg\u002Fm2 for Asians)\n\nExclusion Criteria:\n\n* Treatment with insulin \\>25 IU\n* HbA1c concentration of 12% or more (≥108 mmol\u002Fmol)\n* Insulin to C-peptide ratio \\\u003C0.8 (indicative of insulin deficiency)\n* Myocardial infarction within the previous 6 months, and severe or unstable heart failure or other severe diseases including cancer, psychiatric\u002Feating disorders, severe depression and substance abuse","ALL","24 Years","70 Years",{"count":83,"type":84},600,"ESTIMATED","INTERVENTIONAL",[87],"NA","In this project, the investigators will perform a multicenter randomised controlled trial to determine whether advice to consume a moderate, whole food-based low-carbohydrate high-fat (LCHF) ad libitum diet (CarbCount program) can produce and maintain equal remission rates of type 2 diabetes (T2D) as a nutritionally complete very-low-calorie formula diet followed by a energy-restrictive (i.e., calorie counting) diet (DiRECT principles). Within the principles of each approach, the dietary goals and change will be adjusted according to individual needs\u002Fcapabilities conducive to long-term adherence. Furthermore, the investigators aim to determine whether the rate of diet-induced remission is reflected in\u002Fcan be predicted by baseline or diet-induced changes in glucose variability (e.g., time-in-range measured by continuous glucose monitoring) and other factors such as anthropometric changes and genetic susceptibility. Each center will also conduct locally-lead standalone mechanistic research, including analyses of intra-abdominal\u002Fhepatic fat accumulation, adipose tissue biopsies and\u002For measurements of energy metabolism. Additionally, changes in medication use, nutritional status, cardiovascular disease risk, as well as adverse events, will be monitored.",[90,91,92,93,94,95],"Diabetes Mellitus, Type 2","Overweight and Obesity","Hypertension","Glucose Intolerance","Insulin Resistance","Dyslipidemia Associated With Type II Diabetes Mellitus",[97,22,98,99,100],"Low-carbohydrate high-fat diet","Lifestyle change","Ketogenic diet","Total meal replacement","2022-07-04",{"date":103,"type":104},"2022-07-08","ACTUAL",{"date":106,"type":104},"2022-01-04",{"date":108,"type":84},"2040-12-31",{"name":5,"class":6},1]