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Completed

NCT Number: 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.

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Key information

Conditions

Chromium Deficiency Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Admitted to Anesthesiology Intensive Care Unit

Exclusion criteria

  • Patient Refusal
  • Taking Chromium Supplement

Treatment and study plan

Serum Chromium Level

Diagnostic Test

Measuring serum chromium levels from patients who admitted in intensive care unit.

Primary outcomes

  1. 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).

    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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

    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:

    • LDL cholesterol: Less than 100 mg/dL,
    • HDL cholesterol: Greater than 40 mg/dL for men and greater than 50 mg/dL for women,
    • Triglycerides: Less than 150 mg/dL,
    • Total cholesterol: Less than 200 mg/dL.

  4. 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.

Sponsors and collaborators

Lead sponsor

Oguzhan Kahveci

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2024
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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