Type 2 Diabetes MellitusCKM-T2DNCT07854990
Clinical Predictors and Therapeutic Gaps in CKM Syndrome Among Adults With Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus and Cardiovascular-Kidney-Metabolic Syndrome, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cardiovascular-Kidney-Metabolic Syndrome, Diabetic Kidney Disease
- What is being tested?
- clinical and laboratory CKM staging evaluation
- How many people
- 231 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2026to 10 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Predictors and Therapeutic Gaps Across Stages of Cardio-Renal-Metabolic (CKM) Syndrome Among Adults With Type 2 Diabetes: A Cross-Sectional Study
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).
Read the detailed description
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/CKD), and Stage 4 (clinical CVD or advanced CKD).
- Despite strong clinical trial evidence, a persistent therapeutic gap remains, with fewer than half of eligible T2D patients receiving guideline-indicated organ-protective therapies.
- 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/eGFR, 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.
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular-Kidney-Metabolic Syndrome, Diabetic Kidney Disease
- Being tested
- clinical and laboratory CKM staging evaluation
- Keywords
- CKM syndrome, SGLT2 inhibitors, RAAS inhibitors, Therapeutic gap, Diabetic nephropathy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical and laboratory CKM staging evaluationDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: clinical and laboratory CKM staging evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single outpatient visit
Secondary outcomes (1)
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.
Measured: Single outpatient visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Mar 2028 (estimated)
- Study completion10 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omima Darwish Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854990
- Sponsor's protocol ID
- AUN-CKM-T2D-2026
- Acronym
- CKM-T2D
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Predictors and Therapeutic Gaps Across Stages of Cardio-Renal-Metabolic (CKM) Syndrome Among Adults With Type 2 Diabetes: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07854990
- Acronym / sponsor ID
- CKM-T2D / AUN-CKM-T2D-2026
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular-Kidney-Metabolic Syndrome, Diabetic Kidney Disease
- Keywords
- CKM syndrome, SGLT2 inhibitors, RAAS inhibitors, Therapeutic gap, Diabetic nephropathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 20 Mar 2028 (estimated)
- Study completion
- 10 Jul 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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/CKD), and Stage 4 (clinical CVD or advanced CKD).
- Despite strong clinical trial evidence, a persistent therapeutic gap remains, with fewer than half of eligible T2D patients receiving guideline-indicated organ-protective therapies.
- 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/eGFR, 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult wiith type 2 diabetes | – | Diagnostic Test: clinical and laboratory CKM staging evaluationAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical and laboratory CKM staging evaluationComprehensive 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). | Diagnostic test | adult wiith type 2 diabetes |
Primary outcome
CKM Syndrome Stage Distribution and Clinical Predictors
Time frame: Single outpatient visit
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.
1 secondary outcome
Therapeutic Gap for Organ-Protective Therapies
Time frame: Single outpatient visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Cardiovascular-Kidney-Metabolic Syndrome, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact omima darwish hamam, resident doctor (+201144062818, omima.18313215@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CKM Syndrome Stage Distribution and Clinical Predictors (time frame: Single outpatient visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.