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Autophagy in Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT03583853
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ayat Mostafa, Assiut University

Brief Summary:
Systemic lupus erythematosus is systemic autoimmune disease characterized by a wide range of clinical manifestations, from skin and mucosal lesions to severe injuries in the central nervous system, kidneys and other organs. The presence of high titres of autoantibodies against nuclear components, immune complexes deposition, complement deficiency and lymphocytes infiltration in affected tissues, which causes tissue and organ damage are the main characteristics of the disease. Nowadays, many studies elucidate the essential role of autophagy in the occurrence, development and severity of systemic lupus erythematosus.

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Device: real time PCR

Detailed Description:

Autophagy is a highly conserved lysosome-mediated catabolic process. It can remove unwanted cytoplasmic components, such as long-lived and/or misfolded proteins, damaged organelles, playing an important role in maintaining cellular homeostasis and cell survival in stress conditions, such as nutrient deprivation and hypoxia.

Recently, Autophagy is implicated in nearly all steps of both innate and adaptive immune responses, including neutrophil extracellular trap and inflammasome formation, pathogen recognition, lymphocyte and monocyte development and function, antigen processing and presentation, type I interferon production and inflammatory regulation, thus playing an important part in maintaining the balance of immune system.

Autophagy is divided into three major types: macroautophagy, microautophagy, and chaperone-mediated autophagy, with macroautophagy being the most investigated and understood. Disturbances in autophagy have been implicated in chronic inflammatory diseases and several autoimmune diseases, including Systemic lupus erythematosus, multiple sclerosis, Crohn's disease and rheumatoid arthritis.

Several regulatory factors that may play key roles in autophagy processes have been discovered in recent years, such as beclin1, which is the key regulatory factor in the autophagy startup process, microtubule-associated protein-light chain 3, autophagy-related gene 5, which are components of autophagosomes.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Autophagy Genes and Interleukin-10 in Systemic Lupus Erythematosus Patients
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients
take 5 ml blood for isolation of peripheral blood mono-nuclear cells then extraction of Ribonucleic acid (RNA) to determine the expression of autophagy genes by real time polymerase chain reaction (real time PCR)
Device: real time PCR
real time PCR will be used for determination of expression of autophagy genes

control
take 5 ml blood for isolation of peripheral blood mono-nuclear cells then extraction of RNA to determine the expression of autophagy genes real time polymerase chain reaction
Device: real time PCR
real time PCR will be used for determination of expression of autophagy genes




Primary Outcome Measures :
  1. Change in the expression of autophagy genes in systemic lupus erythematosus patients group and control group [ Time Frame: Baseline and 6 months ]
    the expression of autophagy genes will be measured by real time polymerase chain reaction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
SLE patients are evaluated according to the SLE disease activity index 2000 (SLEDAI) and classified into two groups, one having active disease and the other group with inactive disease
Criteria

Inclusion Criteria:

  • patients who fulfilled at least four criteria of systemic lupus erythematosus according to American College of Rheumatology

Exclusion Criteria:

  • Pregnancy or lactation.
  • coexistence of other autoimmune diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583853


Contacts
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Contact: Mohamed Ali el-feky, prof 00201223971310 mohelfeky@hotmail.com
Contact: Mohamed Saad Badary, prof 00201000103328 Dtn_diatechnology@yahoo.com

Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: Ayat Mostafa, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03583853     History of Changes
Other Study ID Numbers: amkmm
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases