Clinical trial NCT06019286: Novel Predictors of Premature Aging in COPD Patients
Official title: Novel Predictors of Premature Aging in COPD Patients: SCINEXA Score and Laboratory Markers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COPD
Keywords: premature aging
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD attending outpatient clinic either for follow up or newly diagnosed are eligible for inclusion as cases. Control group is non COPD healthy controls.

Brief summary: •Examine whether COPD is associated with accelerated aging using a biological marker of aging and dermatological score

Detailed description: Chronic Obstructive Pulmonary Disease (COPD) results from gene(G)-environment(E) interactions occurring over the lifetime(T) of the individual (GETomics) that can damage the lungs and/or alter their normal development/aging processes.

In COPD, processes including oxidant/antioxidant, protease/antiprotease, and proliferative/ antiproliferative balance, and the control of the inflammatory response become dysfunctional, as in aging. A close relationship between the pathogenesis of COPD and aging has been reviewed, and an increase regarding aging has been identified Aging is defined as a time-dependent progressive loss of physiological integrity, resulting in impaired function and increased vulnerability to death many chronic diseases are dependent on age and encompass physiological mechanisms related to the aging process The interconnection of the different markers of aging has not yet been studied in clinical subjects. We hypothesized that these markers, representing different interrelated aspects of the aging process, are altered in a cohort of COPD patients compared to the control group. These markers include growth hormone(GH), "Red cell distribution width (RDW) and SCINEXA (SCore for INtrinsic and EXtrinsic skin Aging) score as a read-out of biological age. SCINEXA is a validated score which measures the intrinsic and extrinsic factors regarding chronological skin aging and aging due to chronic exposure to ultraviolet (UV) radiation, Respectively.

The major feature of aging is the role of hormones as key regulators of human muscle metabolism and physical function. Growth hormone (GH) actions impact growth, metabolism, and body composition and have been associated with aging and Longevity. While, red cell distribution width (RDW), a part of the standard complete blood count (CBC), is a simple and non-invasive parameter that can be used as a biomarker in evaluating the severity and mortality rates in COPD patients in acute attacks. Also, Elevated RDW has been associated with degenerative conditions in aging.

Eligibility criteria: Inclusion Criteria:

* Patients with COPD attending outpatient are eligible for inclusion as cases. Control group is non COPD healthy controls.

Exclusion Criteria:

* • Patients refused to participate in the study.

  * Patients unable to perform the spirometry test.
  * Patients had a history of hormone disorder or malignant disease.
  * Patients received hormone replacement therapy.

Primary outcomes:
measure: SCINEXA score in relation to COPD patient chronological age.
timeFrame: 1 week
measure: Level of GH and RDW in relation to COPD patient age.
timeFrame: 1 week
measure: Comparing level of GH with the chronological age
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Eman Fathy Ahmed, Dr.
role: STUDY_CHAIR
affiliation: Assiut University
name: Heba Hassan Sayed, DR.
role: STUDY_CHAIR
affiliation: Assiut University
name: Salma Mokhtar Osman, DR.
role: STUDY_CHAIR
affiliation: Assiut University
name: Amal Adel Rayan, Dr.
role: STUDY_CHAIR
References:
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citation: Barnes PJ. Mechanisms of development of multimorbidity in the elderly. Eur Respir J. 2015 Mar;45(3):790-806. doi: 10.1183/09031936.00229714. Epub 2015 Jan 22.
citation: Jiang Z, Han X, Wang Y, Hou T, Dong Y, Han X, Welmer AK, Launer LJ, Du Y, Qiu C. Red cell distribution width, anemia, and lower-extremity physical function among rural-dwelling older adults. Aging Clin Exp Res. 2022 Oct;34(10):2483-2491. doi: 10.1007/s40520-022-02187-9. Epub 2022 Aug 9.
citation: Vierkotter A, Ranft U, Kramer U, Sugiri D, Reimann V, Krutmann J. The SCINEXA: a novel, validated score to simultaneously assess and differentiate between intrinsic and extrinsic skin ageing. J Dermatol Sci. 2009 Mar;53(3):207-11. doi: 10.1016/j.jdermsci.2008.10.001. Epub 2008 Dec 6.