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

NCT07854990 | Not Yet Recruiting

• 1 other identifier: AUN-CKM-T2D-2026
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Type 2 Diabetes Mellitus; Cardiovascular-Kidney-Metabolic Syndrome; Diabetic Kidney Disease

Keywords

CKM syndrome, SGLT2 inhibitors, RAAS inhibitors, Therapeutic gap, Diabetic nephropathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Therapeutic Gap for Organ-Protective Therapies

  Single outpatient visit

Study Arms (1)

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.

Diagnostic Test: clinical and laboratory CKM staging evaluation

Interventions

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).

adult wiith type 2 diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Incomplete essential clinical or laboratory data that cannot be obtained at the visit.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Abutig, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Central Study Contacts

omima darwish hamam, resident doctor

CONTACT

+201144062818; omima.18313215@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor of internal medicine

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): July 10, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)