Novel Predictors of Premature Aging in COPD Patients

NCT ID: NCT06019286

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-04-01

Brief Summary

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

Detailed Description

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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.

Conditions

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COPD

Keywords

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premature aging

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD cases

COPD patients for whom biological marker and dermatological score will be measured

SCINEXA score

Intervention Type DIAGNOSTIC_TEST

\- 18 signs of extrinsic aging of SCINEXA score: sunburn, freckles, actinic lentigo, hyperpigmentation and/or melasma, change in phototype, yellowness, pseudoscars, coarse wrinkles, solar elastosis, cutis rhomboidalis, elastosis, comedones and cysts of Favre-Racouchot, xerosis, teleangectasias, permanent erythema, actinic keratosis, basal cell carcinoma, squamous cell carcinoma and malignant melanoma (extrinsic SCINEXA score). Each item will be scored as 0 (none), 1 (mild), 2 (moderate) or 3 (severe). For some items (uneven pigmentation, cutis rhomboidalis nuchae, elastosis, comedones and cysts of Favre Racouchot, and malignant skin tumors, a binary scale was used: (yes) or (no). Maximun possible score is 54

Control group

non COPD subjects for whom biological marker and dermatological score will be measured

SCINEXA score

Intervention Type DIAGNOSTIC_TEST

\- 18 signs of extrinsic aging of SCINEXA score: sunburn, freckles, actinic lentigo, hyperpigmentation and/or melasma, change in phototype, yellowness, pseudoscars, coarse wrinkles, solar elastosis, cutis rhomboidalis, elastosis, comedones and cysts of Favre-Racouchot, xerosis, teleangectasias, permanent erythema, actinic keratosis, basal cell carcinoma, squamous cell carcinoma and malignant melanoma (extrinsic SCINEXA score). Each item will be scored as 0 (none), 1 (mild), 2 (moderate) or 3 (severe). For some items (uneven pigmentation, cutis rhomboidalis nuchae, elastosis, comedones and cysts of Favre Racouchot, and malignant skin tumors, a binary scale was used: (yes) or (no). Maximun possible score is 54

Interventions

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SCINEXA score

\- 18 signs of extrinsic aging of SCINEXA score: sunburn, freckles, actinic lentigo, hyperpigmentation and/or melasma, change in phototype, yellowness, pseudoscars, coarse wrinkles, solar elastosis, cutis rhomboidalis, elastosis, comedones and cysts of Favre-Racouchot, xerosis, teleangectasias, permanent erythema, actinic keratosis, basal cell carcinoma, squamous cell carcinoma and malignant melanoma (extrinsic SCINEXA score). Each item will be scored as 0 (none), 1 (mild), 2 (moderate) or 3 (severe). For some items (uneven pigmentation, cutis rhomboidalis nuchae, elastosis, comedones and cysts of Favre Racouchot, and malignant skin tumors, a binary scale was used: (yes) or (no). Maximun possible score is 54

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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growth hormone level

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sahar Refaat Mahmoud

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman Fathy Ahmed, Dr.

Role: STUDY_CHAIR

Assiut University

Heba Hassan Sayed, DR.

Role: STUDY_CHAIR

Assiut University

Salma Mokhtar Osman, DR.

Role: STUDY_CHAIR

Assiut University

Amal Adel Rayan, Dr.

Role: STUDY_CHAIR

Assiut University

Central Contacts

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Sahar R Mahmoud, Dr.

Role: CONTACT

Phone: 01002866364

Email: [email protected]

References

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Brat K, Svoboda M, Zatloukal J, Plutinsky M, Volakova E, Popelkova P, Novotna B, Dvorak T, Koblizek V. Prognostic Properties of the GOLD 2023 Classification System. Int J Chron Obstruct Pulmon Dis. 2023 Apr 20;18:661-667. doi: 10.2147/COPD.S410372. eCollection 2023.

Reference Type BACKGROUND
PMID: 37114105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25614163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35943713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19059763 (View on PubMed)

Other Identifiers

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premature aging in COPD

Identifier Type: -

Identifier Source: org_study_id