Chromium Deficiency, Diabetes Mellitus, Hypercholesterolemia, Hyperlipidemias
Conditions
Keywords
Intensive care, Metabolism,glucose, Metabolism,lipid
Brief summary
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.
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.
Interventions
DIAGNOSTIC_TESTSerum Chromium Level
Measuring serum chromium levels from patients who admitted in intensive care unit.
Sponsors
Oguzhan Kahveci
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years old * Admitted to Anesthesiology Intensive Care Unit
Exclusion criteria
* Patient Refusal * Taking Chromium Supplement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Chromium Level | 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
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 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. |
| Blood Glucose | 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. |
| Lipid Profile | 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. |
| Glycemic Variability - Coefficient of Variation (CV) | 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. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Patients who were admitted to the anesthesiology intensive care unit and met the inclusion criteria were recruited between February 2024 and August 2024. The first participant was enrolled on February 7, 2024, and the last participant was enrolled, and primary outcome data collection was completed on August 8, 2024. The study was fully completed on August 14, 2024, following the collection of all secondary outcomes.
Pre-assignment details
All of the enrolled participants were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| Intensive Care Patients Patients who are admitted to the intensive care unit. | 309 |
| Total | 309 |
Baseline characteristics
| Characteristic | Intensive Care Patients | — |
|---|---|---|
| Age, Continuous | 63.72 Years STANDARD_DEVIATION 16.92 | — |
| APACHE - II Score | 9.33 Scores on a scale STANDARD_DEVIATION 5.65 | — |
| Body Mass | 73.8 Kilograms STANDARD_DEVIATION 15.81 | — |
| Body Mass Index (BMI) | 27 kg/m2 STANDARD_DEVIATION 5.36 | — |
| Comorbidities Cardiovascular Diseases | 202 participants | — |
| Comorbidities Diabetes | 89 participants | — |
| Comorbidities Liver Diseases | 4 participants | — |
| Comorbidities Malignancy | 79 participants | — |
| Comorbidities Neurological Disorders | 76 participants | — |
| Comorbidities Respiratory Diseases | 69 participants | — |
| Height | 165.21 Centimeters STANDARD_DEVIATION 9.03 | — |
| Nutritional Status Enteral | 265 Participants | — |
| Nutritional Status Enteral and Parenteral | 42 Participants | — |
| Nutritional Status Parenteral | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Reason for Intensive Care Admission Drug Intoxication | 2 Participants | — |
| Reason for Intensive Care Admission Neurological Disorders | 10 Participants | — |
| Reason for Intensive Care Admission Postoperative Care | 216 Participants | — |
| Reason for Intensive Care Admission Respiratory Distress | 45 Participants | — |
| Reason for Intensive Care Admission Sepsis | 31 Participants | — |
| Reason for Intensive Care Admission Trauma | 5 Participants | — |
| Sex: Female, Male Female | 167 Participants | — |
| Sex: Female, Male Male | 142 Participants | — |
| SOFA Score | 0.91 Scores on a scale STANDARD_DEVIATION 1.77 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Serum Chromium Level
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.
Time frame: Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21).
Population: A total of 309 participants were included in the study. Measurements were taken once a week throughout their hospital stay. In the first measurement (ICU admission/day 0), 309 participants; in the second measurement (participants who completed the 7th day of ICU stay), 51 participants; in the third measurement (participants who completed the 14th day of ICU stay), 24 participants; and in the fourth measurement (participants who completed the 21st day of ICU stay), 13 participants were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intensive Care Patients | Serum Chromium Level | First Measurement (Day 0) | 8.93 µg/L | Standard Deviation 5.18 |
| Intensive Care Patients | Serum Chromium Level | Second Measurement (Day 7) | 9.74 µg/L | Standard Deviation 5.31 |
| Intensive Care Patients | Serum Chromium Level | Third Measurement (Day 14) | 9.68 µg/L | Standard Deviation 4.41 |
| Intensive Care Patients | Serum Chromium Level | Fourth Measurement (Day 21) | 11.01 µg/L | Standard Deviation 4.03 |
Secondary
Blood Glucose
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.
Time frame: Week 1, week 2, week 3 and week 4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intensive Care Patients | Blood Glucose | Third Measurement (Week 3) | 122.29 mg/dL | Standard Deviation 24.47 |
| Intensive Care Patients | Blood Glucose | First Measurement (Week 1) | 128.68 mg/dL | Standard Deviation 35.97 |
| Intensive Care Patients | Blood Glucose | Second Measurement (Week 2) | 122.25 mg/dL | Standard Deviation 27.43 |
| Intensive Care Patients | Blood Glucose | Fourth Measurement (Week 4) | 116.46 mg/dL | Standard Deviation 30.8 |
Secondary
Glycemic Variability - Coefficient of Variation (CV)
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.
Time frame: During each participant's ICU stay (ranging from 1 to 4 weeks).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intensive Care Patients | Glycemic Variability - Coefficient of Variation (CV) | 22.01 Percentage of coefficient of variation | Standard Deviation 12.24 |
Secondary
HbA1c
The HbA1c level when the participant is admitted to the intensive care unit. Possible levels are less/equal/more than %6,5.
Time frame: At the time of ICU admission (day 0).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intensive Care Patients | HbA1c | 5.99 Percentage of glycated hemoglobin (%) | Standard Deviation 1.04 |
Secondary
Lipid Profile
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.
Time frame: Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21).
Population: A total of 309 participants were included in the study. Measurements were taken once a week throughout their hospital stay. In the first measurement (ICU admission/day 0), 309 participants; in the second measurement (participants who completed the 7th day of ICU stay), 51 participants; in the third measurement (participants who completed the 14th day of ICU stay), 24 participants; and in the fourth measurement (participants who completed the 21st day of ICU stay), 13 participants were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intensive Care Patients | Lipid Profile | First Triglycerides Measurement (Day 0) | 118.28 mg/dL | Standard Deviation 74.21 |
| Intensive Care Patients | Lipid Profile | Second Triglycerides Measurement (Day 7) | 135.06 mg/dL | Standard Deviation 58.83 |
| Intensive Care Patients | Lipid Profile | Third Triglycerides Measurement (Day 14) | 124.29 mg/dL | Standard Deviation 57.62 |
| Intensive Care Patients | Lipid Profile | Fourth Triglycerides Measurement (Day 21) | 145.23 mg/dL | Standard Deviation 81.89 |
| Intensive Care Patients | Lipid Profile | First HDL Measurement (Day 0) | 38.93 mg/dL | Standard Deviation 12.08 |
| Intensive Care Patients | Lipid Profile | Second HDL Measurement (Day 7) | 29.7 mg/dL | Standard Deviation 11.92 |
| Intensive Care Patients | Lipid Profile | Third HDL Measurement (Day 14) | 23.9 mg/dL | Standard Deviation 12.63 |
| Intensive Care Patients | Lipid Profile | Fourth HDL Measurement (Day 21) | 22.84 mg/dL | Standard Deviation 11.01 |
| Intensive Care Patients | Lipid Profile | First LDL Measurement (Day 0) | 92.34 mg/dL | Standard Deviation 34.64 |
| Intensive Care Patients | Lipid Profile | Second LDL Measurement (Day 7) | 75.1 mg/dL | Standard Deviation 35.28 |
| Intensive Care Patients | Lipid Profile | Third LDL Measurement (Day 14) | 57.51 mg/dL | Standard Deviation 37.25 |
| Intensive Care Patients | Lipid Profile | Fourth LDL Measurement (Day 21) | 57.69 mg/dL | Standard Deviation 26.51 |
| Intensive Care Patients | Lipid Profile | First VLDL Measurement (Day 0) | 23.86 mg/dL | Standard Deviation 14.85 |
| Intensive Care Patients | Lipid Profile | Second VLDL Measurement (Day 7) | 26.73 mg/dL | Standard Deviation 12.29 |
| Intensive Care Patients | Lipid Profile | Third VLDL Measurement (Day 14) | 24.77 mg/dL | Standard Deviation 11.64 |
| Intensive Care Patients | Lipid Profile | Fourth VLDL Measurement (Day 21) | 31.31 mg/dL | Standard Deviation 23.04 |
| Intensive Care Patients | Lipid Profile | First Total Cholesterol Measurement (Day 0) | 143.14 mg/dL | Standard Deviation 45.79 |
| Intensive Care Patients | Lipid Profile | Second Total Cholesterol Measurement (Day 7) | 116.14 mg/dL | Standard Deviation 46.59 |
| Intensive Care Patients | Lipid Profile | Third Total Cholesterol Measurement (Day 14) | 89.25 mg/dL | Standard Deviation 55.01 |
| Intensive Care Patients | Lipid Profile | Fourth Total Cholesterol Measurement (Day 21) | 82.92 mg/dL | Standard Deviation 42.03 |