O-GlcNAcylation Role in the Pathophysiology of Systemic Lupus Erythematosus (METABOLUPS)
Primary Purpose
Systemic Lupus Erythematosus
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional other trial for Systemic Lupus Erythematosus focused on measuring Systemic lupus erythematosus, autoimmunity, O-GlcNAcylation
Eligibility 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)
Sites / Locations
- CHU de Bordeaux - Service d'Immunologie et ImmunogénétiqueRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Systemic lupus erythematosus (SLE)
Arm Description
Outcomes
Primary Outcome Measures
Quantification of O-GlcNAcylation level in the blood samples of SLE
Secondary Outcome Measures
Disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
score (Min value: 0 - Max value: 105), with higher values mean higher disease activity.
Disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004)
(Min value : 0 - Max value : 4), with higher values mean more severe symptoms
Quantification of OGT biallelic expression in the blood samples of SLE
Full Information
NCT ID
NCT04440566
First Posted
June 17, 2020
Last Updated
November 14, 2022
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04440566
Brief Title
O-GlcNAcylation Role in the Pathophysiology of Systemic Lupus Erythematosus
Acronym
METABOLUPS
Official Title
O-GlcNAcylation Role in the Pathophysiology of Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic lupus erythematosus, autoimmunity, O-GlcNAcylation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Systemic lupus erythematosus (SLE)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
Primary Outcome Measure Information:
Title
Quantification of O-GlcNAcylation level in the blood samples of SLE
Time Frame
At baseline (Day 0)
Secondary Outcome Measure Information:
Title
Disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Description
score (Min value: 0 - Max value: 105), with higher values mean higher disease activity.
Time Frame
At baseline (Day 0)
Title
Disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004)
Description
(Min value : 0 - Max value : 4), with higher values mean more severe symptoms
Time Frame
At baseline (Day 0)
Title
Quantification of OGT biallelic expression in the blood samples of SLE
Time Frame
At baseline (Day 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick BLANCO, Prof
Phone
(0)5 56 79 56 45
Ext
+33
Email
patrick.blanco@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas BARNETCHE, PhD
Phone
(0)5 57 82 04 93
Ext
+33
Email
thomas.barnetche@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick BLANCO, Prof
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux - Service d'Immunologie et Immunogénétique
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick BLANCO, Prof
Phone
(0)5 56 79 56 45
Ext
+33
Email
patrick.blanco@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Thomas BARNETCHE, PhD
Phone
(0)5.57.82.04.93
Ext
+33
Email
thomas.barnetche@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Patrick BLANCO, Prof
First Name & Middle Initial & Last Name & Degree
Christophe RICHEZ, Prof
First Name & Middle Initial & Last Name & Degree
Lionel COUZI, Prof
First Name & Middle Initial & Last Name & Degree
Pierre DUFFAU, Prof
First Name & Middle Initial & Last Name & Degree
Julien SENESCHAL, Prof
First Name & Middle Initial & Last Name & Degree
Estibaliz LAZARO, Prof
12. IPD Sharing Statement
Plan to Share IPD
No
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O-GlcNAcylation Role in the Pathophysiology of Systemic Lupus Erythematosus
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