Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04303208
• Other study ID #: SIRT 3 and SIRT 7 in SSC
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: March 2024

Study information

• Verified date: September 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Systemic sclerosis (SSc) is a systemic autoimmune disease in which inflammation and fibrosis play a crucial role and lead to severe damage and failure of multiple organs such as the skin, joints, tendons, gastrointestinal tract, lungs, heart, blood vessels, and kidneys. It primarily affects women but disease is often more severe in males.

Description:

Systemic sclerosis (SSc) is a systemic autoimmune disease in which inflammation and fibrosis play a crucial role and lead to severe damage and failure of multiple organs such as the skin, joints, tendons, gastrointestinal tract, lungs, heart, blood vessels, and kidneys. It primarily affects women but disease is often more severe in males.

Sirtuins are a class of nicotinamide adenine dinucleotide-consuming enzymes that are implicated in numerous biological pathways .

Sirtuins are considered among the most promising targets for modulating aging-associated cellular and molecular processes and disease pathologies , The majority of studies have shown decreased SIRT expression in tissues and fibroblasts from patients with SSc compared to controls and in experimental fibrosis in mice .

Decreased SIRT3 levels and activity were observed in fibrotic areas of SSc and IPF lung tissues and SSc skin biopsies and explanted fibroblasts compared to controls , Wyman et al investigated the expression of all seven mammalian SIRTs in lung tissues and fibroblasts from patients with SSc and IPF and found a tendency for SIRTs to be decreased in patients with fibrosis compared to controls , with a particularly notable decline in SIRT7 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with systemic sclerosis diagnosed by 2013 ACR\EULAR classification criteria of systemic sclerosis

• Patients' age >18

• 25 rheumatoid arthritis patients as a control .

Exclusion Criteria:

-Overlap or mixed connective tissue diseases.

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Procedure:
• Blood sample
Blood sample ( 5 ml venous blood ) will be obtained under complete aseptic conditions from all eligible participants , using serum separator tube and allow samples to clot for 30 minutes before centrifugation for 15 minutes to obtain clear serum . Separated serum will be stored at < - 20c ( avoid repeated freeze - thaw cycles ) till assessment of Sirt 3 and Sirt 7 levels using Enzyme- linked immunosorbent assay (ELISA) method .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	: To measure circulating Sirt 3 and Sirt 7 levels in patients with systemic sclerosis and their relation with different clinical manifestations	the amount of Sirt 3 and Sirt 7 will be measured by ELISA	2 years
Primary	Influence of Sirt 3 and Sirt 7 in fibrosis in Systemic sclerosis	the amount of Sirt 3 and Sirt 7 will be measured by ELISA	2 years