[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608932":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":54,"collaborators":18,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":80,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Parc Sanitari Pere Virgili","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","The program consists of biweekly in-person and telephone visits, focused on implementing a personalized dietary plan with carbohydrate restriction, based on the American Diabetes Association recommendations; moderate and accessible physical activity; circadian rhythm regularization; and psychological counseling and support.",[13],"Behavioral: CREDOenAP intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","They will receive the standard clinical treatment for diabetes",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","CREDOenAP intervention","Intervention program with intensive lifestyle counseling, added to standard pharmacological treatment subsequently adjusted according to clinical needs and outcomes. The intervention will last 6 months and consists of biweekly in-person and telephone visits. Patients will follow a personalized dietary plan with carbohydrate restriction, based on the recommendations of the American Diabetes Association; engage in moderate and accessible physical activity; implement circadian rhythm regularization; and receive psychological counseling and support.",[9],[26],{"name":27,"affiliation":5,"role":28},"Alexandre Ternianov","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Alexandre Ternianov Principal investigator","CONTACT","+34 932 21 37 85","aternianov@perevirgili.cat",[36],{"facility":5,"status":18,"city":37,"state":18,"zip":18,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Barcelona","Spain","ES",{"type":41,"coordinates":42},"Point",[43,44],2.15899,41.38879,{"lat":44,"lon":43},[47,51],{"name":48,"role":32,"phone":49,"phoneExt":18,"email":50},"Neus Carrilero Primary and Community Care Research Coordinator","+ 34 659 77 29 79","ncarrilero@perevirgili.cat",{"name":52,"role":32,"phone":18,"phoneExt":18,"email":53},"Aida Veras Primary and Community Care Researcher","averas@perevirgili.cat",{"type":55,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100608932","lifestyle-intervention-for-type-2-diabetes-in-primary-care-credoenap-100608932",false,"NCT07207980","Lifestyle Intervention for Type 2 Diabetes in Primary Care (CREDOenAP)","Lifestyle Intervention Clinical Trial for the Remission of Type 2 Diabetes Mellitus in Primary Care (CREDOenAP)","CREDOenAP","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Men and women aged 18-80 years, inclusive.\n3. Confirmed diagnosis of T2DM according to recognized diagnostic criteria\n4. Most recent recorded hemoglobin A1c (HbA1c) \\> 6.5%.\n5. Body Mass Index (BMI) greater than 27 kg\u002Fm².\n\nExclusion Criteria:\n\n1. Failure to meet the diagnostic criteria for T2DM in the screening laboratory tests.\n2. Being dependent for basic activities of daily living (Barthel score ≤ 90 points).\n3. Lack of willingness to cooperate with the follow-up of the lifestyle intervention plan.\n4. Presence of serious or terminal comorbidities significantly worsening short- to medium-term prognosis (active cancer, terminal chronic diseases, myocardial infarction within the last 6 months, acute heart failure or NYHA stage ≥ III, etc.).\n5. History of ketoacidosis.\n6. Presence of criteria or potential autoimmune insulinopenia (abnormal C-peptide, anti-GAD+ antibodies, pattern of basal and\u002For glucose-stimulated hypoinsulinemia).\n7. Cognitive impairment.\n8. Weight loss exceeding 5 kg in the past 6 months.\n9. Significant changes in physical activity and\u002For dietary patterns in the past 6 months.\n10. History of eating disorders.\n11. History of substance abuse.\n12. History of severe psychiatric disorders.\n13. Pregnancy or intention to become pregnant within the study period.","ALL","18 Years","80 Years",{"count":68,"type":69},120,"ESTIMATED","INTERVENTIONAL",[72],"NA","The purpose of this clinical trial is to determine whether an intensive lifestyle intervention can achieve remission of type 2 diabetes mellitus (T2DM) in adult patients treated in primary care. The main questions the study seeks to answer are:\n\n* What proportion of participants achieve diabetes remission after 6 months of intervention?\n* How many participants maintain remission 12 months after completing the program (18 months total)?\n\nParticipants will:\n\n* Follow a personalized dietary plan with carbohydrate restriction.\n* Engage in moderate, accessible physical activity.\n* Implement strategies to improve circadian rhythm regularity.\n* Receive psychological counseling and support.",[75],"Type 2 Diabetes Mellitus (T2DM)",[75,77,78,79],"Diabetes Remission","Lifestyle Intervention","Primary Care","NOT_YET_RECRUITING","2025-09-26",{"date":83,"type":84},"2025-10-06","ACTUAL",{"date":86,"type":69},"2026-01-11",{"date":88,"type":69},"2028-01-11",{"name":5,"class":6},1]