- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06334042
Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit
The goal of this observational study is to determine 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 sample 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.
Study Overview
Status
Intervention / Treatment
Detailed 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 will be included in the study. A single blood sample (into trace element serum sample 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 International Business Machines Statistical Product and Service Solutions (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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Ankara, Turkey, 06230
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years old
- Admitted to Anesthesiology Intensive Care Unit
Exclusion Criteria:
- Patient Refusal
- Taking Chromium Supplement
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Intensive Care Patients
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Measuring serum chromium levels from patients who admitted in intensive care unit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum Chromium Level
Time Frame: Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21).
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Serum chromium levels of participants were measured once a week throughout the participant's ICU stay, starting from admission.
The healthy reference range of 0.7 to 28.0 µg/L for blood chromium levels was used.
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Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HbA1c
Time Frame: At the time of ICU admission (day 0).
|
The HbA1c level when the participant is admitted to the intensive care unit.
Possible levels are less/equal/more than %6,5.
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At the time of ICU admission (day 0).
|
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Blood Glucose
Time Frame: Week 1, week 2, week 3 and week 4.
|
During the ICU stay, participants underwent daily blood glucose measurements using the fingertip method.
Weekly averages of the measurements were calculated.
Although there is no accepted definition of acute hyperglycemia in the critical care setting, it is generally considered to be above 180 - 220 mg/dL.
In our study, we considered the value of 200 mg/dL as a threshold for stress hyperglycemia.
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Week 1, week 2, week 3 and week 4.
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Lipid Profile
Time Frame: Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21).
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Lipid Profiles (HDL, LDL, Triglycerides, Total Cholesterol) of participants were measured once a week throughout the participant's ICU stay, starting from admission. The optimal lipid levels vary depending on age, gender, and other risk factors; however, they are generally recommended within the following ranges:
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Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21).
|
|
Glycemic Variability - Coefficient of Variation (CV)
Time Frame: During each participant's ICU stay (ranging from 1 to 4 weeks).
|
The coefficient of variation (CV) is the standard deviation divided by the mean of the glycemic values.
A higher coefficient of variation is associated with greater glycemic variability.
A CV of < 36% is a good threshold.
The coefficients of variation were calculated after each participant was discharged from the ICU, based on all the blood glucose values measured during their stay.
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During each participant's ICU stay (ranging from 1 to 4 weeks).
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 23/488
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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