Novel Predictors of Premature Aging in COPD Patients

August 25, 2023 updated by: Sahar Refaat Mahmoud, Assiut University

Novel Predictors of Premature Aging in COPD Patients: SCINEXA Score and Laboratory Markers

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COPD cases
COPD patients for whom biological marker and dermatological score will be measured
Diagnostic test: 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
Other Names:
  • growth hormone level
Control group
non COPD subjects for whom biological marker and dermatological score will be measured
Diagnostic test: 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
Other Names:
  • growth hormone level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCINEXA score in relation to COPD patient chronological age.
Time Frame: 1 week
measuring SCINEXA score (Score for Intrinsic and Extrinsic skin Aging) in COPD patients and in control group and comparing it with chronological age. - 18 signs of extrinsic aging, 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
1 week
Level of GH and RDW in relation to COPD patient age.
Time Frame: 1 week
measuring level of GH and in COPD patients and control group
1 week
Comparing level of GH with the chronological age
Time Frame: 1 week
Compare level of GH with the chronological age of patients and controls to detected premature aging
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Eman Fathy Ahmed, Dr., Assiut University
  • Study Chair: Heba Hassan Sayed, DR., Assiut University
  • Study Chair: Salma Mokhtar Osman, DR., Assiut University
  • Study Chair: Amal Adel Rayan, Dr., Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

August 19, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Estimated)

August 31, 2023

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • premature aging in COPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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