Chromium DeficiencyNCT06334042
Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit
An observational study of Chromium Deficiency and Diabetes Mellitus, run by Oguzhan Kahveci at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chromium Deficiency, Diabetes Mellitus, Hyperlipidemias
- What is being tested?
- Serum Chromium Level
- How many people
- 309 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2024to 14 Aug 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Every patient; who is over/and 18 years old age, admitted to Anesthesiology Intensive Care Unit, agreed to participate in the study (with informed consent) and not - taking chromium supplement
Who may be able to join
- Age ≥ 18 years old
- Admitted to Anesthesiology Intensive Care Unit
Who cannot join
- Patient Refusal
- Taking Chromium Supplement
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Serum Chromium Level
- Keywords
- Intensive care, Metabolism,glucose, Metabolism,lipid
- Medical subject headings
- Diabetes Mellitus, Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Chromium LevelDiagnostic test
Measuring serum chromium levels from patients who admitted in intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Care Patients | Not described Receives: Diagnostic Test: Serum Chromium Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21).
Secondary outcomes (4)
HbA1c
The HbA1c level when the participant is admitted to the intensive care unit. Possible levels are less/equal/more than %6,5.
Measured: At the time of ICU admission (day 0).
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.
Measured: Week 1, week 2, week 3 and week 4.
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.
Measured: 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)
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.
Measured: During each participant's ICU stay (ranging from 1 to 4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start7 Feb 2024
- Primary completion8 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chromium DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oguzhan Kahveci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oguzhan Kahveci, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334042
- Sponsor's protocol ID
- GO 23/488
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2024
- Last updated
- 13 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will discuss this matter with all the researchers and ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06334042
- Acronym / sponsor ID
- GO 23/488
- Keywords
- Intensive care, Metabolism,glucose, Metabolism,lipid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Oguzhan KahveciUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Posted 13 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive Care Patients | – | Diagnostic Test: Serum Chromium Level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient; who is over/and 18 years old age, admitted to Anesthesiology Intensive Care Unit, agreed to participate in the study (with informed consent) and not - taking chromium supplement
Key inclusion criteria (2 listed)
- Age ≥ 18 years old
- Admitted to Anesthesiology Intensive Care Unit
Key exclusion criteria (2 listed)
- Patient Refusal
- Taking Chromium Supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum Chromium LevelMeasuring serum chromium levels from patients who admitted in intensive care unit. | Diagnostic test | Intensive Care Patients |
Primary outcome
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.
4 secondary outcomes
HbA1c
Time frame: At the time of ICU admission (day 0).
Blood Glucose
Time frame: Week 1, week 2, week 3 and week 4.
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).
Glycemic Variability - Coefficient of Variation (CV)
Time frame: During each participant's ICU stay (ranging from 1 to 4 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. We will discuss this matter with all the researchers and ethics committee.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chromium Deficiency and Diabetes Mellitus, run by Oguzhan Kahveci at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.