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Not yet recruitingNCT07506824Updated Apr 2, 2026

Effect of Glucose Variability on Morbidity and Mortality in Diabetic Patients Admitted in Coronary Care Unit

An observational study in Glycemic Variability in Coronary Patients, sponsored by Sohag University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Glycemic Variability in Coronary Patients
03

In context

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  • Aged ≥18 year.
  • Both sexes.
  • Diabetic Patient with coronary heart diseases only .
  • Non-diabetic patients or those with unknown diabetes status.

Inclusion criteria

  1. Aged ≥18 year.
  2. Both sexes.
  3. Diabetic Patient with coronary heart diseases only .

Exclusion criteria

Exclusion Criteria:

    • Non-diabetic patients or those with unknown diabetes status.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Effect of Glucose variability on Morbidity and Mortality in Diabetic Patients Admitted in Coronary Care Unit

    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

    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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07506824
Lead sponsor
Sohag University
Responsible party
Mohamed Ibrahim Mohamed (Resident of internal medicine, Sohag University) — Principal investigator
First posted
Apr 2, 2026
Start date
Mar 20, 2026 (estimated)
Primary completion
Sep 20, 2026 (estimated)
Completion
Nov 20, 2026 (estimated)
Last update
Apr 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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