Glycemic Variability in Coronary PatientsNCT07506824
Effect of Glucose Variability on Morbidity and Mortality in Diabetic Patients Admitted in Coronary Care Unit
An observational study of Glycemic Variability in Coronary Patients, run by Sohag University.
Trial summary
The study is to assess the effect of glycemic variability on morbidity and mortality in diabetic patient during admission in Coronary care unit in sohag university. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glycemic Variability in Coronary Patients
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2026to 20 Nov 2026
- 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: * Aged ≥18 year. * Both sexes. * Diabetic Patient with coronary heart diseases only . * Non-diabetic patients or those with unknown diabetes status.
Who may be able to join
- Aged ≥18 year.
- Both sexes.
- Diabetic Patient with coronary heart diseases only .
Who cannot join
- • Non-diabetic patients or those with unknown diabetes status.
About this study
The study is to assess the effect of glycemic variability on morbidity and mortality in diabetic patient during admission in Coronary care unit in sohag university.
Read the detailed description
Diabetes mellitus (DM) is a major public health problem worldwide and represents one of the most important risk factors for cardiovascular disease. Patients with diabetes have a significantly higher incidence of coronary artery disease (CAD), acute coronary syndrome (ACS), heart failure, and cardiovascular mortality compared with non-diabetic individuals. The coexistence of diabetes and cardiovascular disease leads to more complex clinical courses and worse outcomes, particularly during acute hospital admissions to the Coronary Care Unit (CCU) [1,2].
Hyperglycemia during acute illness has long been recognized as a predictor of adverse outcomes in critically ill patients, including those with ACS. Stress-induced hyperglycemia results from increased counter-regulatory hormones, inflammatory cytokines, and insulin resistance, all of which are commonly present during acute myocardial ischemia. Numerous studies have demonstrated that elevated blood glucose levels at admission and during hospitalization are associated with increased morbidity and mortality in both diabetic and non-diabetic patients admitted to intensive and coronary care units [3,4].
In recent years, attention has shifted toward glucose variability (GV), which refers to fluctuations in blood glucose concentrations over time. Glucose variability includes both intra-day and inter-day glycemic excursions and is considered an important component of dys glycemia. Growing evidence suggests that glucose variability may have a more deleterious effect than sustained hyperglycemia by promoting oxidative stress, endothelial dysfunction, inflammation, and apoptosis, all of which play crucial roles in the pathophysiology of cardiovascular complications [5,6].
Experimental and clinical studies have shown that acute glucose fluctuations can induce greater oxidative stress than chronic stable hyperglycemia. These fluctuations are associated with endothelial damage, increased platelet activation, impaired autonomic function, and arrhythmogenesis, which may worsen outcomes in patients with acute coronary events [7]. In critically ill patients, increased glucose variability has been linked to higher rates of infections, prolonged hospital stay, and increased mortality, independent of mean glucose levels [8].
In patients admitted to the CCU, particularly those with diabetes, glucose control is challenging due to variable nutritional intake, use of vasoactive drugs, acute organ dysfunction, and insulin resistance. While current guidelines emphasize avoidance of severe hyperglycemia and hypoglycemia, they provide limited guidance on minimizing glucose variability. Several observational studies have suggested that higher glucose variability during hospitalization is associated with increased short-term and long-term mortality in patients with ACS and those requiring intensive care [9,10]. However, data specifically focusing on diabetic patients admitted to the CCU remain limited, and the independent contribution of glucose variability to morbidity and mortality in this population is not fully understood.
Understanding the relationship between glucose variability and clinical outcomes in diabetic patients during CCU admission is of great clinical importance. Identifying glucose variability as a modifiable risk factor could influence glucose management strategies, optimize insulin protocols, and ultimately improve patient outcomes. Therefore, this study aims to evaluate the association between glucose variability and morbidity and mortality in diabetic patients admitted to the Coronary Care Unit.
GV will be measure by random blood sugar of the patient during admission and calculate of mean blood sugar and standard deviation of random blood sugar.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Glucose variability on Morbidity and Mortality in Diabetic Patients Admitted in Coronary Care Unit
- All-cause in-hospital mortality: Death from any cause during CCU admission.
- Major adverse cardiovascular events (MACE)
Composite of:
Cardiovascular death Reinfarction Stroke Need for urgent revascularization
Measured: Recruitment Period: 3 months Patient Follow-up: In-hospital: up to discharge (≤30 days) Post-discharge (optional): 30 days Total Study Duration: 6 months from mars 2026 to September 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start20 Mar 2026 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic Variability in Coronary PatientsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506824
- Sponsor's protocol ID
- Soh-Med-26-2-4MS
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glucose Variability on Morbidity and Mortality in Diabetic Patients Admitted in Coronary Care Unit
- ClinicalTrials.gov ID
- NCT07506824
- Acronym / sponsor ID
- Soh-Med-26-2-4MS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 2 Apr 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.
The study is to assess the effect of glycemic variability on morbidity and mortality in diabetic patient during admission in Coronary care unit in sohag university.
Detailed description
Diabetes mellitus (DM) is a major public health problem worldwide and represents one of the most important risk factors for cardiovascular disease. Patients with diabetes have a significantly higher incidence of coronary artery disease (CAD), acute coronary syndrome (ACS), heart failure, and cardiovascular mortality compared with non-diabetic individuals. The coexistence of diabetes and cardiovascular disease leads to more complex clinical courses and worse outcomes, particularly during acute hospital admissions to the Coronary Care Unit (CCU) [1,2].
Hyperglycemia during acute illness has long been recognized as a predictor of adverse outcomes in critically ill patients, including those with ACS. Stress-induced hyperglycemia results from increased counter-regulatory hormones, inflammatory cytokines, and insulin resistance, all of which are commonly present during acute myocardial ischemia. Numerous studies have demonstrated that elevated blood glucose levels at admission and during hospitalization are associated with increased morbidity and mortality in both diabetic and non-diabetic patients admitted to intensive and coronary care units [3,4].
In recent years, attention has shifted toward glucose variability (GV), which refers to fluctuations in blood glucose concentrations over time. Glucose variability includes both intra-day and inter-day glycemic excursions and is considered an important component of dys glycemia. Growing evidence suggests that glucose variability may have a more deleterious effect than sustained hyperglycemia by promoting oxidative stress, endothelial dysfunction, inflammation, and apoptosis, all of which play crucial roles in the pathophysiology of cardiovascular complications [5,6].
Experimental and clinical studies have shown that acute glucose fluctuations can induce greater oxidative stress than chronic stable hyperglycemia. These fluctuations are associated with endothelial damage, increased platelet activation, impaired autonomic function, and arrhythmogenesis, which may worsen outcomes in patients with acute coronary events [7]. In critically ill patients, increased glucose variability has been linked to higher rates of infections, prolonged hospital stay, and increased mortality, independent of mean glucose levels [8].
In patients admitted to the CCU, particularly those with diabetes, glucose control is challenging due to variable nutritional intake, use of vasoactive drugs, acute organ dysfunction, and insulin resistance. While current guidelines emphasize avoidance of severe hyperglycemia and hypoglycemia, they provide limited guidance on minimizing glucose variability. Several observational studies have suggested that higher glucose variability during hospitalization is associated with increased short-term and long-term mortality in patients with ACS and those requiring intensive care [9,10]. However, data specifically focusing on diabetic patients admitted to the CCU remain limited, and the independent contribution of glucose variability to morbidity and mortality in this population is not fully understood.
Understanding the relationship between glucose variability and clinical outcomes in diabetic patients during CCU admission is of great clinical importance. Identifying glucose variability as a modifiable risk factor could influence glucose management strategies, optimize insulin protocols, and ultimately improve patient outcomes. Therefore, this study aims to evaluate the association between glucose variability and morbidity and mortality in diabetic patients admitted to the Coronary Care Unit.
GV will be measure by random blood sugar of the patient during admission and calculate of mean blood sugar and standard deviation of random blood sugar.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Aged ≥18 year. * Both sexes. * Diabetic Patient with coronary heart diseases only . * Non-diabetic patients or those with unknown diabetes status.
Key inclusion criteria (3 listed)
- Aged ≥18 year.
- Both sexes.
- Diabetic Patient with coronary heart diseases only .
Key exclusion criteria (1 listed)
- • Non-diabetic patients or those with unknown diabetes status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of Glucose variability on Morbidity and Mortality in Diabetic Patients Admitted in Coronary Care Unit
Time frame: Recruitment Period: 3 months Patient Follow-up: In-hospital: up to discharge (≤30 days) Post-discharge (optional): 30 days Total Study Duration: 6 months from mars 2026 to September 2026
1. All-cause in-hospital mortality: Death from any cause during CCU admission. 2. Major adverse cardiovascular events (MACE) Composite of: Cardiovascular death Reinfarction Stroke Need for urgent revascularization
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 Apr 2026.
Related trials for Glycemic Variability in Coronary Patients
Not yet recruiting
Impact of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Cardiac Surgery Patients
Cardiac Surgery, Insulin Resistance
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glycemic Variability in Coronary Patients, run by Sohag University.
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 1 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 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Glucose variability on Morbidity and Mortality in Diabetic Patients Admitted in Coronary Care Unit (time frame: Recruitment Period: 3 months Patient Follow-up: In-hospital: up to discharge (≤30 days) Post-discharge (optional): 30 days Total Study Duration: 6 months from mars 2026 to September 2026). 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 Apr 2026.