Clinical Predictors and Therapeutic Gaps in CKM Syndrome Among Adults With Type 2 Diabetes

ConditionsType 2 Diabetes Mellitus Cardiovascular-Kidney-Metabolic Syndrome Diabetic Kidney Disease

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAssiut University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older.

Established diagnosis of type 2 diabetes mellitus (ADA criteria) for at least 6 months with diabetic kidney disease (DKD), obesity, or cardiac affection.

Willing and able to give written informed consent.

Disqualifiers

Type 1 or secondary diabetes.

Already on chronic dialysis or with a functioning kidney transplant.

Pregnancy.

Active malignancy or terminal illness with life expectancy <6 months.

Trial population

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

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

clinical and laboratory CKM staging evaluation
Diagnostic test
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/eGFR, 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).

Treatment groups

231 Participants

are divided into 1 treatment group

Group A: adult wiith type 2 diabetes1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Single outpatient visit

Secondary outcomes

Therapeutic Gap for Organ-Protective Therapies

Percentage of eligible patients not prescribed guideline-indicated organ-protective therapies (SGLT2 inhibitors, GLP-1 receptor agonists, ACEi/ARB, statins, and mineralocorticoid receptor antagonists), calculated per drug class and across CKM stages.

Time frame

Single outpatient visit

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: