Genotyping of SIRT1in Chronic Obstructive Pulmonary DiseaseNCT06055634
SIRT1(rs7069102 ) Gene Polymorphism in Chronic Obstructive Pulmonary Disease at Egyptian Patients
An observational study of Genotyping of SIRT1in Chronic Obstructive Pulmonary Disease, run by Sohag University at 1 site in Egypt.
Trial summary
Chronic obstructive pulmonary disease (COPD) prevalence, morbidity, and mortality vary across countries and across different groups within countries with a direct relation to the prevalence of tobacco smoking. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Genotyping of SIRT1in Chronic Obstructive Pulmonary Disease
- What is being tested?
- genotyping of SIRT1 in chronic obstructive patients
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- Adult, Older adult
Study population: A total of 100 individuals at high risk for COPD were studied from approval of the ethical committee of the Faculty of Medicine, Sohag University. Informed consent was obtained from all participants. 100 healthy control. All participants will subject to the following: (1) A questionnaire including age, sex, smoking status, presence of chronic cough, chronic sputum production, chest wheezing, and shortness of breath; grading of dyspnea using a modified medical research council (MMRC) dyspnea scale. (2) General examination, including measurements of body weight, height, and BMI. (3) Local chest examination.
Who may be able to join
- All patients admitted to Sohag University Hospital, chest department.
Who cannot join
- Patients with malignancies, any other chronic disease, Individuals with a history of known chronic cardiorespiratory diseases and those with collagen vascular diseases were excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag, Sohag
Magdy M Amin, professor
About this study
Chronic obstructive pulmonary disease (COPD) prevalence, morbidity, and mortality vary across countries and across different groups within countries with a direct relation to the prevalence of tobacco smoking. Other risk factors for COPD include genetic factors, longstanding asthma, outdoor air pollution, second-hand smoke exposure, biomass smoke, indoor air pollution, occupational exposures, and tuberculosis . The prevalence and burden of COPD are projected to increase in the coming decades because of continued exposure to COPD risk factors and the changing age structure of the world's population. As these factors are rapidly increasing in developing countries, COPD will become a major health problem, exerting a huge demand on economic and healthcare resources in developing countries [2]. In Egypt, although COPD is a rising significant health problem, data on its prevalence, morbidity, and mortality are still lacking and have to be estimated .
Sirtuin 1 (SIRT1) is a protein/histone deacetylase dependent NAD. It plays a crucial role in various human diseases such as cardiovascular diseases, cancer, inflammation, aging, neurodegenerative disease, obesity and type 2 diabetes. Seven isoforms of the SIRT1 gene (SIRT1- SIRT7) have been determined in mammals. Expression of the SIRT1 gene is regulated by transcription factors such as CREB, FOXO3, HIC1, NF-KB, p53, PARP-2 and PPAR. SIRT1
- Being tested
- genotyping of SIRT1 in chronic obstructive patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genotyping of SIRT1 in chronic obstructive patientsGenetic
genotyping of SIRT1 in chronic obstructive patients
| Study group | Role | What they receive |
|---|---|---|
| patients more than 40 years | Not described Receives: Genetic: genotyping of SIRT1 in chronic obstructive patients | |
| patients less than 40 years | Not described Receives: Genetic: genotyping of SIRT1 in chronic obstructive patients | |
| controls | Not described Receives: Genetic: genotyping of SIRT1 in chronic obstructive patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIRT1(rs7069102 ) Gene polymorphism in chronic obstructive pulmonary disease
genotyping of sirt1 in chronic obstructive pulmonary disease
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Genotyping of SIRT1in Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Mahmoud Kadry, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055634
- Sponsor's protocol ID
- Soh-Med-23-09-10PD
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eisner MD, Anthonisen N, Coultas D, Kuenzli N, Perez-Padilla R, Postma D, Romieu I, Silverman EK, Balmes JR; Committee on Nonsmoking COPD, Environmental and Occupational Health Assembly. An official American Thoracic Society public policy statement: Novel risk factors and the global burden of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 Sep 1;182(5):693-718. doi: 10.1164/rccm.200811-1757ST.
PubMed 20802169Chan-Yeung M, Ait-Khaled N, White N, Ip MS, Tan WC. The burden and impact of COPD in Asia and Africa. Int J Tuberc Lung Dis. 2004 Jan;8(1):2-14.
PubMed 14974740Zarrabeitia MT, Valero C, Martin-Escudero JC, Olmos JM, Bolado-Carrancio A, de Sande-Nacarino EL, Rodriguez-Rey JC, Sainz J, Riancho JA. Association study of sirtuin 1 polymorphisms with bone mineral density and body mass index. Arch Med Res. 2012 Jul;43(5):363-8. doi: 10.1016/j.arcmed.2012.06.012. Epub 2012 Jul 21.
PubMed 22824213Rahman I, Kinnula VL, Gorbunova V, Yao H. SIRT1 as a therapeutic target in inflammaging of the pulmonary disease. Prev Med. 2012 May;54 Suppl(Suppl):S20-8. doi: 10.1016/j.ypmed.2011.11.014. Epub 2011 Dec 8.
PubMed 22178470
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIRT1(rs7069102 ) Gene Polymorphism in Chronic Obstructive Pulmonary Disease at Egyptian Patients
- ClinicalTrials.gov ID
- NCT06055634
- Acronym / sponsor ID
- Soh-Med-23-09-10PD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic obstructive pulmonary disease (COPD) prevalence, morbidity, and mortality vary across countries and across different groups within countries with a direct relation to the prevalence of tobacco smoking. Other risk factors for COPD include genetic factors, longstanding asthma, outdoor air pollution, second-hand smoke exposure, biomass smoke, indoor air pollution, occupational exposures, and tuberculosis . The prevalence and burden of COPD are projected to increase in the coming decades because of continued exposure to COPD risk factors and the changing age structure of the world's population. As these factors are rapidly increasing in developing countries, COPD will become a major health problem, exerting a huge demand on economic and healthcare resources in developing countries [2]. In Egypt, although COPD is a rising significant health problem, data on its prevalence, morbidity, and mortality are still lacking and have to be estimated .
Sirtuin 1 (SIRT1) is a protein/histone deacetylase dependent NAD. It plays a crucial role in various human diseases such as cardiovascular diseases, cancer, inflammation, aging, neurodegenerative disease, obesity and type 2 diabetes. Seven isoforms of the SIRT1 gene (SIRT1- SIRT7) have been determined in mammals. Expression of the SIRT1 gene is regulated by transcription factors such as CREB, FOXO3, HIC1, NF-KB, p53, PARP-2 and PPAR. SIRT1
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients more than 40 years | – | Genetic: genotyping of SIRT1 in chronic obstructive patients |
| patients less than 40 years | – | Genetic: genotyping of SIRT1 in chronic obstructive patients |
| controls | – | Genetic: genotyping of SIRT1 in chronic obstructive patients |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 100 individuals at high risk for COPD were studied from approval of the ethical committee of the Faculty of Medicine, Sohag University. Informed consent was obtained from all participants. 100 healthy control. All participants will subject to the following: (1) A questionnaire including age, sex, smoking status, presence of chronic cough, chronic sputum production, chest wheezing, and shortness of breath; grading of dyspnea using a modified medical research council (MMRC) dyspnea scale. (2) General examination, including measurements of body weight, height, and BMI. (3) Local chest examination.
Key inclusion criteria (1 listed)
- All patients admitted to Sohag University Hospital, chest department.
Key exclusion criteria (1 listed)
- Patients with malignancies, any other chronic disease, Individuals with a history of known chronic cardiorespiratory diseases and those with collagen vascular diseases were excluded.
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 |
|---|---|---|
| genotyping of SIRT1 in chronic obstructive patientsgenotyping of SIRT1 in chronic obstructive patients | Genetic | controls, patients less than 40 years, patients more than 40 years |
Primary outcome
SIRT1(rs7069102 ) Gene polymorphism in chronic obstructive pulmonary disease
Time frame: 2 months
genotyping of sirt1 in chronic obstructive pulmonary disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 20802169Eisner MD, Anthonisen N, Coultas D, Kuenzli N, Perez-Padilla R, Postma D, Romieu I, Silverman EK, Balmes JR; Committee on Nonsmoking COPD, Environmental and Occupational Health Assembly. An official American Thoracic Society public policy statement: Novel risk factors and the global burden of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 Sep 1;182(5):693-718. doi: 10.1164/rccm.200811-1757ST.
- Background: PubMed 14974740Chan-Yeung M, Ait-Khaled N, White N, Ip MS, Tan WC. The burden and impact of COPD in Asia and Africa. Int J Tuberc Lung Dis. 2004 Jan;8(1):2-14.
- Background: PubMed 22824213Zarrabeitia MT, Valero C, Martin-Escudero JC, Olmos JM, Bolado-Carrancio A, de Sande-Nacarino EL, Rodriguez-Rey JC, Sainz J, Riancho JA. Association study of sirtuin 1 polymorphisms with bone mineral density and body mass index. Arch Med Res. 2012 Jul;43(5):363-8. doi: 10.1016/j.arcmed.2012.06.012. Epub 2012 Jul 21.
- Background: PubMed 22178470Rahman I, Kinnula VL, Gorbunova V, Yao H. SIRT1 as a therapeutic target in inflammaging of the pulmonary disease. Prev Med. 2012 May;54 Suppl(Suppl):S20-8. doi: 10.1016/j.ypmed.2011.11.014. Epub 2011 Dec 8.
- Individual participant dataSharing planned: Undecided
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.
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 Genotyping of SIRT1in Chronic Obstructive Pulmonary Disease, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zeinab M Kadry, lecturer (01225960747, zainbmahmoud@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIRT1(rs7069102 ) Gene polymorphism in chronic obstructive pulmonary disease (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06055634, which also lists 4 linked publications.
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 28 Sep 2023.