[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"obese-diabetics\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:obese-diabetics":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100594260",false,"NCT07017127","Remission of Type 2 Diabetes With Lifestyle Intervention","Remission of Type 2 Diabetes With Mediterranean Diet, Physical Activity and Psychological Support: a Randomized Clinical Trial","REMeDI2ME","Inclusion Criteria:\n\n* type 2 diabetes diagnosis\n* incident cases or diagnosed not more than 7 years ago\n* body mass index of 27-45 kg\u002Fm²\n\nExclusion Criteria:\n\n* mobility restriction\n* use of mobility aids\n* insulin therapy\n* HbA1c \\>12%\n* TSH \\>10 mU\u002FL\n* heart failure (NYHA III, NYHA IV)\n* use of obesity pharmacotherapy (orlistat, GLP-1 receptor agonists, GLP-1\u002FGIP dual agonists) for less than 6 months\n* weight loss greater than 5 kg in the last 6 months\n* chronic kidney disease and estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73 m2\n* active treatment of proliferative diabetic retinopathy with anti-VEGF\n* heart attack or stroke in the past 1 year\n* active malignant disease diagnosed in the past 1 year\n* eating disorders\n* pregnancy or pregnancy planning\n* substance abuse\n* learning disabilities\n* acute episode of severe depression\n* current use of antipsychotics\n* food allergy","ALL","20 Years","69 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to achieve diabetes type 2 (DM2) remission using intensive lifestyle intervention.\n\nThe main questions it aims to answer are:\n\n* Does intensive lifestyle intervention (including Mediterranean diet with a caloric deficit, daily physical activity, increase in stress resilience and group support) lead to DM2 remission (HbA1c\\\u003C6.5%, without medications)\n* Can intensive lifestyle intervention (including Mediterranean diet with a caloric deficit, daily physical activity, increase in stress resilience and group support) result to weight loss of \\>15 kg\n* Does intensive lifestyle intervention result in any side effects (secondary outcome)\n\nResearchers will compare intensive lifestyle intervention to the usual clinical care (control group).\n\nParticipants in the experimental group will:\n\n* eat Mediterranean diet with a caloric deficit\n* perform daily physical activity\n* increase their stress resilience with psychosocial support of the group\n* enroll weekly in individual and group counseling and workshops for 6 months, following with 1.5 years of follow-up",[27,28],"Diabetes Mellitus Type 2","Obese Diabetics",[30,31,32,33,34,35],"diabetes remission","Mediterranean diet","physical activity","stress","weight loss","healthy lifestyle","RECRUITING","2025-06-10",{"date":39,"type":40},"2025-06-12","ACTUAL",{"date":42,"type":40},"2025-05-01",{"date":44,"type":21},"2027-12-17",{"name":46,"class":47},"University of Split, School of Medicine","OTHER",""]