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O-GlcNAcylation Role in the Pathophysiology of Systemic Lupus Erythematosus (METABOLUPS)

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ClinicalTrials.gov Identifier: NCT04440566
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : November 15, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
This study aims at defining the role of O-GlcNAcylation is in the physiopathology of systemic lupus erythematosus (SLE). O-GlcNAcylation is a metabolic pathway potentially implicated in SLE with potential for the discovery of new therapeutic strategies.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: blood sample Not Applicable

Detailed Description:

Systemic lupus erythematosus (SLE) is a rare and potentially life-threatening auto-immune systemic disease. There is an urgent need for better comprehension of the physiopathology of the disease and to discover new therapeutic pathways.

The hexosamine biosynthesis pathway, or HBP, is an important regulator of immunity and results in a post-transductional modification of proteins called O-GlcNAcylation and involved in inflammation and immunity.

There is a very unbalanced sex ratio in favor of women in SLE suggesting a role of the X chromosome in the physiopathology of the disease. The human OGT gene (a key O-GlcNAcylation enzyme) is localized on the X chromosome, near the XIST gene responsible for the inactivation of one X chromosome by methylation.

Moreover, genes encoding CD40L, CXCR3 and OGT have been shown to be demethylated and overexpressed in T cells of women with systemic systemic lupus erythematosus compared to men with the same pathology.

The investigators hypothesize that O-GlcNAcylation is increased in the effector lymphocytes of SLE patients and involved in the pathophysiology of the disease. Therefore, inhibiting O-GlcNAcylation may be a promising therapeutic option in SLE.

This study will recruit 100 patients with SLE followed in Bordeaux University Hospital. Among classical disease activity information, blood samples will be collected at study visit to study O-GlcNAcylation levels in immune cells. Fundamental research will be realized on patients' sample.

Clinical and biological disease activity, treatment and outcomes will be studied in correlation with O-GlcNAcylation levels. Patients will be included within their usual follow-up. No extra visit will be needed and blood samples will be drawn at the same times as those drawn for clinical purposes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: O-GlcNAcylation Role in the Pathophysiology of Systemic Lupus Erythematosus
Actual Study Start Date : October 13, 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Systemic lupus erythematosus (SLE) Biological: blood sample
30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation




Primary Outcome Measures :
  1. Quantification of O-GlcNAcylation level in the blood samples of SLE [ Time Frame: At baseline (Day 0) ]

Secondary Outcome Measures :
  1. Disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: At baseline (Day 0) ]
    score (Min value: 0 - Max value: 105), with higher values mean higher disease activity.

  2. Disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004) [ Time Frame: At baseline (Day 0) ]
    (Min value : 0 - Max value : 4), with higher values mean more severe symptoms

  3. Quantification of OGT biallelic expression in the blood samples of SLE [ Time Frame: At baseline (Day 0) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient aged over 18 years old
  • Diagnosis of systemic lupus erythematosus
  • Affiliated person or beneficiary of a social security scheme.
  • Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research).

Exclusion Criteria:

  • Pregnant or breastfeeding women,
  • Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)

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): NCT04440566


Contacts
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Contact: Patrick BLANCO, Prof (0)5 56 79 56 45 ext +33 patrick.blanco@chu-bordeaux.fr
Contact: Thomas BARNETCHE, PhD (0)5 57 82 04 93 ext +33 thomas.barnetche@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux - Service d'Immunologie et Immunogénétique Recruiting
Bordeaux, France
Contact: Patrick BLANCO, Prof    (0)5 56 79 56 45 ext +33    patrick.blanco@chu-bordeaux.fr   
Contact: Thomas BARNETCHE, PhD    (0)5.57.82.04.93 ext +33    thomas.barnetche@chu-bordeaux.fr   
Principal Investigator: Patrick BLANCO, Prof         
Sub-Investigator: Christophe RICHEZ, Prof         
Sub-Investigator: Lionel COUZI, Prof         
Sub-Investigator: Pierre DUFFAU, Prof         
Sub-Investigator: Julien SENESCHAL, Prof         
Sub-Investigator: Estibaliz LAZARO, Prof         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Patrick BLANCO, Prof CHU Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04440566    
Other Study ID Numbers: CHUBX 2020/06
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: November 15, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Systemic lupus erythematosus
autoimmunity
O-GlcNAcylation
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases