Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

Official Title
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Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Procedure: Blood sample


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: study group<br>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 . | Procedure: Blood sample<br>* 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 .<br>|
| Other: control group<br>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 . | Procedure: Blood sample<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| : 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 | 
| 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 |