Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit

Diabetes Mellitus Clinical Trial

Official title:

Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334042
• Other study ID #: GO 23/488
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: Oguzhan Kahveci, MD
• Phone: +903123051207
• Email: oguzhan.kahveci[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn about the effects of chromium serum levels on glucose metabolism, lipid metabolism, morbidity and mortality rates in critically ill intensive care patients. The investigators' goal is to provide a different perspective on solving the common problems of hyperglycemia and dyslipidemia encountered in intensive care patients, aiming to reduce morbidity and mortality rates.

Participants will give a single blood sample (into trace element serum tube) on the day of admission to the intensive care unit, along with routine blood tests, and samples will be taken once a week during their stay in the intensive care unit.

Description:

Hyperglycemia is a common risk factor in critically ill patients admitted to intensive care units; increasing hospital stay duration, morbidity/mortality rates and is associated with increased undesirable cardiovascular events, thrombosis, inflammatory changes, impaired immune functions, increased infection frequency, delayed wound healing, osmotic diuresis, fluid - electrolyte imbalances and other issues.

Dyslipidemia plays a significant role in the development of atherosclerosis and consequently cardiovascular disease.

Chromium (Cr) is a trace metal. It has been claimed that trivalent chromium is a cofactor of a low molecular weight chromium - binding substance (LMWCr; also known as chromodulin), an oligopeptide. LMWCr can enhance the action of insulin, thereby improving tissue insulin sensitivity and facilitating glucose transport into the cells. This hypothesis is supported by observations that chromium deficiency leads to an increase in blood sugar, total cholesterol and triglycerides; a decrease in high - density lipoproteins (HDL) and insulin sensitivity.

Patients aged 18 and older admitted to the Intensive Care Unit of Hacettepe University Department of Anesthesiology and Reanimation will be included in the study. A single blood sample (into trace element serum tube) will be taken from participants in the study group on the day of admission to the intensive care unit, along with routine blood tests, and samples will be taken once a week during their stay in the intensive care unit. The chromium level in the collected blood samples will be analyzed using inductively coupled plasma - mass spectrometry (ICP - MS). The laboratory results of the monitored participants will be prospectively recorded in the data collection form and in IBM SPSS.

A literature review revealed very few publications on the effects of chromium serum levels on glucose metabolism, lipid metabolism, morbidity and mortality rates; and the existing publications did not include samples of critically ill intensive care patients. With this study, the investigators aim to contribute to the national and international literature with a large sample of intensive care patients. Thus, the investigators' goal is to provide a different perspective on solving the common problems of hyperglycemia and dyslipidemia encountered in intensive care patients, aiming to reduce morbidity and mortality rates.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old age

• Admitted to Anesthesiology Intensive Care Unit

Exclusion Criteria:

• Patient Refusal

• Taking Chromium Supplement

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypercholesterolemia
• Hyperlipidemias

Intervention

Diagnostic Test:
• Serum Chromium Level
Measuring serum chromium levels from patients who admitted in intensive care unit.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Oguzhan Kahveci

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Chromium Level	Initial Chromium level when the participant is admitted to the intensive care unit. Every week control measurement will be conducted until the participant is discharged. Possible levels are less/equal/more than 1,4 micrograms/liter.	Through study completion, an average of six months.
Secondary	HbA1c	Initial HbA1c level when the participant is admitted to the intensive care unit. Possible levels are less/equal/more than %6,5	Through study completion, an average of six months.
Secondary	Blood Glucose	Daily blood glucose measurement of the participants.	Through study completion, an average of six months.
Secondary	Lipid Profile	Initial Lipid Profile (HDL, LDL, Triglycerides, Total Cholesterol) measurement when the participant is admitted to the intensive care unit.	Through study completion, an average of six months.