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Trial registered on ANZCTR
Registration number
ACTRN12625000450415
Ethics application status
Approved
Date submitted
13/09/2024
Date registered
13/05/2025
Date last updated
13/05/2025
Date data sharing statement initially provided
13/05/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Role of the CONUT Score in Assessing Malnutrition, Inflammation, and Mortality in Diabetic Patients Admitted to the Intensive Care Unit
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Scientific title
The Role of the CONUT Score in Assessing Malnutrition, Inflammation, and Mortality in Diabetic Patients Admitted to the Intensive Care Unit
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Secondary ID [1]
312722
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nil known
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Universal Trial Number (UTN)
U1111-1311-7245
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Trial acronym
CONUT (Controlling Nutritional Status)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
diabetes mellitus
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Requirement for intensive care
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Condition category
Condition code
Metabolic and Endocrine
331304
331304
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0
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The CONUT (Controlling Nutritional Status) score is a widely used screening tool for assessing the nutritional status of individuals in clinical practice. This score is calculated based on three biochemical parameters:
Serum albumin level: A marker of protein reserves.
Total lymphocyte count: An indicator of cellular immune function.
Total cholesterol level: A reflection of energy reserves.
The CONUT score is derived from the combination of these three parameters. A total CONUT score >2 is considered indicative of a risk for malnutrition, while a score of <2 is regarded as normal nutritional status.
Serum albumin concentration, total lymphocyte count and total cholesterol data will be recorded in blood samples collected from patients at designated time points on day 0, week 1, week 2 and month 1 during admission to the intensive care unit and throughout follow-up. In addition, the thickness of the rectus femoris muscle will be measured using ultrasound by an anesthesiologist who has performed at least 50 measurements.
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Intervention code [1]
329245
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary outcome of the study is to evaluate the relationship between the admission CONUT score of diabetic patients and 1-month mortality. Since the CONUT score allows for the assessment of malnutrition, the relationship between patients' malnutrition status and 1-month mortality will also be examined.
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Assessment method [1]
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Serum analysis results will be recorded at specified time points (day 0 - admission, week 1, week 2, month 1) for diabetic patients admitted to the intensive care unit. The CONUT score will be calculated based on the values of albumin (g/dL), total lymphocyte count (count/mm³), and total cholesterol (mg/dL). During the 1-month follow-up of the patients, ICU discharge and mortality status will be recorded.
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Timepoint [1]
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Day 0 - admission day and 1 month after admission (primary timepoints)
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Secondary outcome [1]
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The relationship between sarcopenia determined using rectus femoris muscle thickness and the CONUT score.
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Assessment method [1]
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Rectus femoris muscle thickness measured by ultrasound
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Timepoint [1]
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1 week after admission, 2 weeks after admission
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Eligibility
Key inclusion criteria
-Patients aged between 18 and 99
-Patients diagnosed with diabetes
-Patients requiring ICU admission
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
-Patients with a history of leukemia/lymphoma or a diagnosis of malignancy
-Patients with a history of drug use that may cause bone marrow depression
-Patients with a history of cirrhosis
-Pregnant women
-Patients with incomplete laboratory data
-Patient with dialysis
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/11/2024
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Date of last participant enrolment
Anticipated
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Actual
1/02/2025
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Date of last data collection
Anticipated
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Actual
1/03/2025
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Sample size
Target
60
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Accrual to date
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Final
60
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Recruitment outside Australia
Country [1]
26558
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Turkey
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State/province [1]
26558
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Funding & Sponsors
Funding source category [1]
317151
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
317151
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Primary sponsor type
Individual
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Name
Berrak Sebil Aydin MD (Department of Anaesthesiology and Reanimation, Karadeniz Eregli Government Hospital)
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Address
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Country
Turkey
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
319419
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Country [1]
319419
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315902
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Zonguldak Bülent Ecevit University Non-Interventional Clinical Research Ethics Committee
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Ethics committee address [1]
315902
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Bülent Ecevit University Faculty of Medicine, Ethics Committee Chairmanship 67th Km Kozlu Road, 67100 Kozlu Zonguldak, Turkey
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Ethics committee country [1]
315902
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Turkey
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Date submitted for ethics approval [1]
315902
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11/09/2024
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Approval date [1]
315902
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16/10/2024
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Ethics approval number [1]
315902
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Ethics committee name [2]
316119
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Zonguldak Bülent Ecevit University Non-Interventional Clinical Research Ethics Committee
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Ethics committee address [2]
316119
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Bülent Ecevit University Faculty of Medicine, Ethics Committee Chairmanship 67th Km Kozlu Road, 67100 Kozlu Zonguldak, Turkey
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Ethics committee country [2]
316119
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Turkey
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Date submitted for ethics approval [2]
316119
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11/09/2024
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Approval date [2]
316119
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Ethics approval number [2]
316119
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Summary
Brief summary
The CONUT score is a scoring system used to assess immuno-nutritional status, incorporating values of albumin (g/dL), total lymphocyte count (count/mm³), and total cholesterol (mg/dL). The CONUT score is an efficient, accurate, and user-friendly tool for early detection and continuous monitoring of hospital malnutrition. Total cholesterol reflects calorie deficiencies; albumin indicates protein reserves; and lymphocyte count represents immunological defense. A high score, resulting from decreased values in each component, indicates poor nutritional status. Albumin plays a role in various functions such as nutrition, molecular transport, and colloid pressure. Malnutrition hinders lymphocyte formation and reduces circulating lymphocyte counts. Inflammation can induce Type 2 diabetes by increasing insulin resistance, and hyperglycemia can exacerbate inflammation, creating a vicious cycle. The net effect may manifest as increased long-term complications and mortality in diabetes. In conclusion, close monitoring of immuno-nutritional status and appropriate nutritional care in diabetic patients may contribute to improved prognosis. Therefore, we aimed to evaluate the relationship between CONUT score and immuno-malnutrition status in diabetic patients to determine 30-day mortality.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Berrak Sebil Aydin
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Address
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Kdz. Eregli State Hospital Hastane Street, No: 1 Kdz. Eregli, Zonguldak Turkey Postal Code: 67300
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Country
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Turkey
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Phone
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+905058178141
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Fax
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Email
136154
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[email protected]
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Contact person for public queries
Name
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Berrak Sebil Aydin
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Address
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Kdz. Eregli State Hospital Hastane Street, No: 1 Kdz. Eregli, Zonguldak Turkey Postal Code: 67300
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Country
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Turkey
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Phone
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+905058178141
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Berrak Sebil Aydin
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Address
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Kdz. Eregli State Hospital Hastane Street, No: 1 Kdz. Eregli, Zonguldak Turkey Postal Code: 67300
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Country
136156
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Turkey
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Phone
136156
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+905058178141
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Fax
136156
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Email
136156
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
ethic.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF