[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608932":3},{"organization":4,"outcomesModule":7,"designInfo":97,"detailedDescription":96,"studyPopulation":96,"armGroups":103,"interventions":114,"overallOfficials":120,"centralContacts":124,"locations":130,"responsibleParty":149,"collaborators":96,"id":151,"slug":96,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":152,"sex":158,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":96,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":174,"whyStopped":96,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"Parc Sanitari Pere Virgili","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":96},[9],{"measure":10,"description":11,"timeFrame":12},"Presence of T2DM remission","Glycated hemoglobin (HbA1c): T2DM remission will be considered if HbA1c is \\\u003C 6.5% after 6 months of intervention and at least 3 months without antidiabetic medication. HbA1c will be determined by blood analysis after a minimum of 8 hours of fasting\n\nFasting plasma glucose: T2DM remission will be considered if fasting venous plasma glucose is \\\u003C 126 mg\u002FdL after 6 months of intervention and at least 3 months without antidiabetic medication. Fasting plasma glucose will be measured by venous blood analysis after a minimum of 8 hours of fasting","After 6 months of intervention and 12 months after the intervention",[14,18,21,24,27,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72,75,77,80,83,87,90,93],{"measure":15,"description":16,"timeFrame":17},"Blood pressure","Blood pressure will be measured three times after the participant has been seated at rest for 10 minutes with uncrossed legs. The mean of the last two measurements will be used for statistical analysis. Systolic and diastolic blood pressure will be reported in mmHg using a brachial cuff sphygmomanometer.","After 6 months of intervention and 12 months after the intervention.",{"measure":19,"description":20,"timeFrame":12},"Total cholesterol","Measured in mg\u002FdL via blood analysis.",{"measure":22,"description":23,"timeFrame":12},"HDL cholesterol","High-density lipoprotein (HDL) cholesterol measured in mg\u002FdL via blood analysis.",{"measure":25,"description":26,"timeFrame":12},"LDL cholesterol","Low-density lipoprotein (LDL) cholesterol measured in mg\u002FdL via blood analysis.",{"measure":28,"description":29,"timeFrame":12},"Apolipoprotein B100 (ApoB100)","A protein involved in cholesterol transport and relevant for evaluating elevated cholesterol causes, measured in mg\u002FdL via blood analysis.",{"measure":31,"description":32,"timeFrame":12},"Triglycerides","Measured in mg\u002FdL via blood analysis",{"measure":34,"description":35,"timeFrame":12},"Presence and size of atherosclerotic plaques in carotid arteries","Assessed via Doppler ultrasound of the supraaortic trunks. If plaques are present, the total plaque area will be measured in cm², and changes in plaque area will be tracked throughout the study.",{"measure":37,"description":38,"timeFrame":12},"Weight","Measured in kilograms (kg)",{"measure":40,"description":41,"timeFrame":12},"Body Mass Index (BMI)","Calculated from weight and height using the formula: BMI = weight (kg) \u002F \\[height (m)\\]².",{"measure":43,"description":44,"timeFrame":12},"Abdominal circumference","Measured at the midpoint between the lowest rib and the iliac crest during maximal inspiration and expiration, in centimeters (cm)",{"measure":46,"description":47,"timeFrame":12},"Insulin resistance","Evaluated using the HOMA-IR index (Homeostasis Model Assessment of Insulin Resistance), which estimates insulin resistance and beta-cell function. Determined via blood analysis after a minimum 8-hour fast. Values above 2.5 may indicate T2D. Calculated as: \\[fasting insulin (μU\u002FmL) x glucemia basal (mmol\u002FL)\\] \u002F 22.5 = \\[fasting insulin (μU\u002FmL) x (Glucemia basal (mg\u002FdL) x 0,0555)\\] \u002F 22.5",{"measure":49,"description":50,"timeFrame":12},"Pancreatic activity","Assessed using the HOMA-B index, which evaluates the function and activity of pancreatic beta cells. HOMA-B, together with HOMA-IR, helps in the diagnosis of T2D. Values between 167 and 175 are considered normal and not indicative of T2D. Values below this range suggest impaired beta-cell function, resulting in insufficient insulin production (insulinopenia).",{"measure":52,"description":53,"timeFrame":12},"Fasting insulin","Measures the amount of insulin in a blood sample. Insulin is a hormone produced by the pancreas. Normal values range between 5-25 U\u002FmL. It will be measured via blood analysis after a minimum 8-hour fast.",{"measure":55,"description":56,"timeFrame":12},"Metabolic Syndrome Diagnosis","Metabolic Syndrome Diagnosis is established if at least three of the following five criteria are present:\n\n* Abdominal circumference: Men of European descent \\> 94 cm; Women of European descent \\> 80 cm. For other ethnicities, cut-off points are defined according to the International Diabetes Federation (IDF). (López De La Torre et al., 2010)\n* Fasting glucose: \\> 100 mg\u002FdL or receiving pharmacological treatment for hyperglycemia.\n* Triglycerides: \\> 150 mg\u002FdL or receiving lipid-lowering therapy.\n* HDL cholesterol: \\\u003C 40 mg\u002FdL in men; \\\u003C 50 mg\u002FdL in women, or receiving lipid-lowering therapy.\n* Blood pressure: Systolic \\> 130 mmHg or Diastolic \\> 85 mmHg, or receiving antihypertensive treatment.",{"measure":58,"description":59,"timeFrame":12},"NAFLD Liver Fat Score","Non-alcoholic fatty liver disease (NAFLD) is a condition characterized by excessive fat accumulation in the liver. Its severity can vary according to the score: \\\u003C -1.455 low risk, -1.455 to 0.675 intermediate risk, \\> 0.675 high risk (Angulo et al., 2007; Kotronen et al., 2009).\n\nThe calculation is determined using the following formula:\n\n-2.89 + 1.18 × Metabolic Syndrome (Yes = 1 \u002F No = 0) + 0.45 × T2DM (Yes = 2 \u002F No = 0) + 0.15 × Fasting Insulin (mU\u002FL) + 0.04 × Fasting Serum AST (U\u002FL) - 0.94 × AST\u002FALT ratio",{"measure":61,"description":62,"timeFrame":12},"NAFLD Fibrosis Score","The identification and quantification of fibrosis are clinically relevant since fibrosis is associated with an unfavorable clinical prognosis. An NFS \\> 0.676 indicates the presence of advanced fibrosis (Angulo et al., 2007; Kotronen et al., 2009). The calculation is determined using the following formula:\n\n-1.675 + 0.037 × Age (years) + 0.094 × BMI (kg\u002Fm²) + 1.13 × IFG\u002Fdiabetes (Yes = 1 \u002F No = 0) + 0.99 × AST\u002FALT ratio - 0.013 × Platelets (×10⁹\u002FL) - 0.66 × Albumin (g\u002FdL)",{"measure":64,"description":65,"timeFrame":12},"Physical activity","Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ)",{"measure":67,"description":68,"timeFrame":12},"Nutritional and energy composition:","The 24-hour dietary recall questionnaire will be administered at each biweekly visit",{"measure":70,"description":71,"timeFrame":12},"Smoking habits","Measured by a study-specific questionnaire",{"measure":73,"description":74,"timeFrame":12},"Alcohol consumption","Alcohol intake will be quantified using a questionnaire combined with a standardized alcohol unit conversion calculator",{"measure":76,"description":71,"timeFrame":12},"Circadian habits",{"measure":78,"description":79,"timeFrame":12},"Health status","SF-36: This is a generic scale that provides a health status profile and is applicable both to patients and to the general population",{"measure":81,"description":82,"timeFrame":12},"Medication consumption","Defined Daily Dose (DDD) by active substance: DDDs of the active substances consumed will be classified according to ATC7. Each ATC classification has a defined daily dose based on international standards, which determine the recommended maximum daily amount for the approved indication of the active substance",{"measure":84,"description":85,"timeFrame":86},"Number of hypoglycemia episodes","Episodes of hypoglycemia detected by patients through capillary blood glucose levels and\u002For recorded in eCAP during the intervention (plasma glucose \\\u003C60 mg\u002Fdl)","During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention",{"measure":88,"description":89,"timeFrame":86},"Number of symptomatic hyperglycemia episodes","Episodes of hyperglycemia recorded in eCAP during the intervention (plasma glucose \\>350 mg\u002Fdl accompanied by compatible symptoms such as general malaise, nausea, asthenia, among others)",{"measure":91,"description":92,"timeFrame":86},"Total number of healthcare visits","Annual contacts with the healthcare system including Primary Care (physicians and nursing), Specialized Care, and Emergency Care",{"measure":94,"description":95,"timeFrame":86},"Number of diabetes-related emergency episodes","Emergency visits related to diabetes during the intervention period",null,{"allocation":98,"interventionModel":99,"interventionModelDescription":96,"primaryPurpose":100,"observationalModel":96,"timePerspective":96,"maskingInfo":101},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":102,"maskingDescription":96,"whoMasked":96},"NONE",[104,110],{"label":105,"type":106,"description":107,"interventionNames":108},"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.",[109],"Behavioral: CREDOenAP intervention",{"label":111,"type":112,"description":113,"interventionNames":96},"Control group","NO_INTERVENTION","They will receive the standard clinical treatment for diabetes",[115],{"type":116,"name":117,"description":118,"armGroupLabels":119,"otherNames":96},"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.",[105],[121],{"name":122,"affiliation":5,"role":123},"Alexandre Ternianov","PRINCIPAL_INVESTIGATOR",[125],{"name":126,"role":127,"phone":128,"phoneExt":96,"email":129},"Alexandre Ternianov Principal investigator","CONTACT","+34 932 21 37 85","aternianov@perevirgili.cat",[131],{"facility":5,"status":96,"city":132,"state":96,"zip":96,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":140,"contacts":141},"Barcelona","Spain","ES",{"type":136,"coordinates":137},"Point",[138,139],2.15899,41.38879,{"lat":139,"lon":138},[142,146],{"name":143,"role":127,"phone":144,"phoneExt":96,"email":145},"Neus Carrilero Primary and Community Care Research Coordinator","+ 34 659 77 29 79","ncarrilero@perevirgili.cat",{"name":147,"role":127,"phone":96,"phoneExt":96,"email":148},"Aida Veras Primary and Community Care Researcher","averas@perevirgili.cat",{"type":150,"investigatorFullName":96,"investigatorTitle":96,"investigatorAffiliation":96,"oldNameTitle":96,"oldOrganization":96},"SPONSOR","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":162,"type":163},120,"ESTIMATED","INTERVENTIONAL",[166],"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.",[169],"Type 2 Diabetes Mellitus (T2DM)",[169,171,172,173],"Diabetes Remission","Lifestyle Intervention","Primary Care","NOT_YET_RECRUITING","2025-09-26",{"date":177,"type":178},"2025-10-06","ACTUAL",{"date":180,"type":163},"2026-01-11",{"date":182,"type":163},"2028-01-11",{"name":5,"class":6},1]