Clinical trial NCT05718453: Assessment of Trace Elements, Systemic Inflammation and Electrolytes
Official title: Assessment of Trace Elements, Systemic Inflammation and Electrolytes in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Copd
Keywords: COPD
Biomarkers
Trace elements
Electrolytes
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.
Primary purpose: TREATMENT

Brief summary: COPD is one of the most common causes of health problems worldwide. It is a disease that is associated with several systemic features that affect its morbidity and mortality.

Detailed description: The most prominent features of COPD are systemic inflammation and oxidative stress. There is growing interest in establishing the significance of systemic inflammatory biomarkers in COPD patients, as they could be useful in evaluating exacerbations, monitoring disease progression, and evaluating treatment outcomes.

C-reactive protein (CRP) is a biomarker for systemic inflammation, produced mostly by hepatocytes in response to tissue injury or inflammation.

Tumor necrosis factor - alpha (TNF-α) is a key modulator of the immune system's response to infection. At the sites of inflammation, this cytokine regulates the function of poly-morphs and lymphocytes, with essentially protective benefits for the host. Increased TNF-α production may enhance an injury process locally and also elevated circulating levels may have negative systemic consequences.

Trace elements are hypothesized to play a role in the pathogenesis of many diseases, either directly or indirectly. Trace elements play an important function in the inhibition and activation of enzyme processes .

Zinc, for example, is a co-factor for various enzymes and is important for cell membrane stability, protein synthesis, proper tissue growth, and nucleic acid metabolism.

Severity of COPD exacerbation is associated with increased levels of copper (Cu) and zinc (Zn).

Patients with COPD are liable for various electrolyte derangements, especially during exacerbations. Hyponatremia is typically observed in the final stages of COPD. Hypokalemia may also occur independently or concomitantly with hyponatremia, and because magnesium plays a role in muscle tone, a drop in magnesium levels in COPD is a component that reduces respiratory muscle function and causes muscle fatigue.

Eligibility criteria: Inclusion Criteria:

* COPD patients

Exclusion Criteria:

* Patients with Cardiovascular diseases,
* diabetes mellitus,
* chronic kidney disease,
* chronic liver disease,
* collagen vascular diseases,
* cancer,
* currently smoking,
* current pneumonia or inflammation, or refused to participate in the study

Primary outcomes:
measure: Assessment of the pain resulted in COPD
timeFrame: from baseline to 72 hours
measure: Number of participants with abnormal laboratory test results
timeFrame: from baseline to 48 hours after the taking blood samle
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia university
Study officials:
affiliation: Department of Internal medicine Minia university, Minia, Egypt
name: Mohammad O Abdel Aziz, Professor
role: STUDY_DIRECTOR
References: