[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658596":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":20,"studyPopulation":21,"armGroups":22,"interventions":28,"overallOfficials":17,"centralContacts":34,"locations":40,"responsibleParty":53,"collaborators":17,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":17,"enrollmentInfo":67,"targetDuration":17,"studyType":70,"phases":17,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":78,"whyStopped":17,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"CKM Syndrome Stage Distribution and Clinical Predictors","Classification of participants into CKM stages (0-4) per 2023 AHA criteria, and determination of independent clinical and laboratory predictors (e.g., age, BMI, eGFR, UACR, comorbidities) associated with advanced CKM stages (Stages 3-4) using multivariate logistic regression.","Single outpatient visit",[14],{"measure":15,"description":16,"timeFrame":12},"Therapeutic Gap for Organ-Protective Therapies","Percentage of eligible patients not prescribed guideline-indicated organ-protective therapies (SGLT2 inhibitors, GLP-1 receptor agonists, ACEi\u002FARB, statins, and mineralocorticoid receptor antagonists), calculated per drug class and across CKM stages.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":6,"timePerspective":19,"maskingInfo":17},"CROSS_SECTIONAL","Type 2 diabetes (T2D) affects a rapidly growing proportion of the global population, ranking alongside cardiovascular and chronic kidney disease as leading causes of death worldwide. T2D accelerates cardiovascular-renal-metabolic (CVRM) dysfunction through chronic inflammation, neurohormonal activation, and endothelial injury. The AHA 2023 staging framework categorizes CKM into Stage 0 (no risk), Stage 1 (excess adiposity), Stage 2 (metabolic risk factors including T2D, hypertension, early CKD), Stage 3 (subclinical CVD\u002FCKD), and Stage 4 (clinical CVD or advanced CKD).\n\n* Despite strong clinical trial evidence, a persistent therapeutic gap remains, with fewer than half of eligible T2D patients receiving guideline-indicated organ-protective therapies.\n* In this single-visit observational study conducted at Assiut University Hospitals, eligible adult T2D patients will undergo structured clinical examination, standard laboratory evaluations (fasting blood glucose, HbA1c, lipid profile, serum creatinine\u002FeGFR, spot urine albumin-to-creatinine ratio, serum potassium), 12-lead ECG, abdominal ultrasound, and echocardiography. Participants will be staged according to CKM criteria. Logistic regression models will determine independent predictors of advanced CKM disease, and prescribed regimens will be audited against guidelines to calculate drug class-specific therapeutic gaps.","Adult patients (aged ≥18 years) with an established diagnosis of type 2 diabetes mellitus (ADA criteria) for at least 6 months, accompanied by diabetic kidney disease (DKD), obesity, or cardiac involvement, attending routine follow-up at the outpatient diabetes and internal medicine clinics of Assiut University Hospitals, Assiut, Egypt",[23],{"label":24,"type":17,"description":25,"interventionNames":26},"adult wiith type 2 diabetes","Adult patients aged 18 years and older with established type 2 diabetes mellitus (duration ≥6 months) and diabetic kidney disease, obesity, or cardiac affection attending outpatient clinics at Assiut University Hospitals.",[27],"Diagnostic Test: clinical and laboratory CKM staging evaluation",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":17},"DIAGNOSTIC_TEST","clinical and laboratory CKM staging evaluation","Comprehensive single-visit assessment including clinical examination (BP, BMI, waist circumference, 12-lead ECG), routine laboratory testing (fasting blood glucose, HbA1c, lipid profile, serum creatinine\u002FeGFR, spot urine albumin-to-creatinine ratio, serum potassium), abdominal ultrasound, and echocardiography to classify CKM syndrome stage (0-4) per AHA 2023 criteria and evaluate current prescribing patterns of organ-protective therapies\\[span\\_1\\](start\\_span)\\[span\\_1\\](end\\_span).",[24],[35],{"name":36,"role":37,"phone":38,"phoneExt":17,"email":39},"omima darwish hamam, resident doctor","CONTACT","+201144062818","omima.18313215@med.aun.edu.eg",[41],{"facility":42,"status":17,"city":43,"state":44,"zip":17,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":17},"Assiut university","Asyut","Abutig","Egypt","EG",{"type":48,"coordinates":49},"Point",[50,51],31.18368,27.18096,{"lat":51,"lon":50},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Omima Darwish Ahmed","resident doctor of internal medicine","100658596","clinical-predictors-and-therapeutic-gaps-in-ckm-syndrome-among-adults-with-type-2-diabetes-100658596",false,"NCT07854990","Clinical Predictors and Therapeutic Gaps in CKM Syndrome Among Adults With Type 2 Diabetes","Clinical Predictors and Therapeutic Gaps Across Stages of Cardio-Renal-Metabolic (CKM) Syndrome Among Adults With Type 2 Diabetes: A Cross-Sectional Study","CKM-T2D","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Established diagnosis of type 2 diabetes mellitus (ADA criteria) for at least 6 months with diabetic kidney disease (DKD), obesity, or cardiac affection.\n* Willing and able to give written informed consent.\n\nExclusion Criteria:\n\n* Type 1 or secondary diabetes.\n* Already on chronic dialysis or with a functioning kidney transplant.\n* Pregnancy.\n* Active malignancy or terminal illness with life expectancy \\\u003C6 months.\n* Incomplete essential clinical or laboratory data that cannot be obtained at the visit.","ALL","18 Years",{"count":68,"type":69},231,"ESTIMATED","OBSERVATIONAL","Type 2 diabetes (T2D) is a principal driver of cardiovascular-renal-metabolic (CKM) syndrome, where metabolic, renal, and cardiac dysfunction accelerate disease progression. This cross-sectional study aims to classify adult patients with T2D attending outpatient clinics at Assiut University Hospitals across CKM stages (0-4) according to the 2023 American Heart Association (AHA) staging system. Additionally, the study identifies independent clinical and laboratory predictors of advanced CKM stages (Stages 3-4) and quantifies the therapeutic gap regarding guideline-indicated organ-protective medications (SGLT2 inhibitors, GLP-1 receptor agonists, RAAS inhibitors, statins, and MRAs).",[73,74,75],"Type 2 Diabetes Mellitus","Cardiovascular-Kidney-Metabolic Syndrome","Diabetic Kidney Disease",[77],"CKM syndrome, SGLT2 inhibitors, RAAS inhibitors, Therapeutic gap, Diabetic nephropathy","NOT_YET_RECRUITING","2026-09-27",{"date":81,"type":82},"2026-10-02","ACTUAL",{"date":84,"type":69},"2026-10-20",{"date":86,"type":69},"2028-07-10",{"name":5,"class":6},1]