跳至主要内容
临床试验/NCT04440566
NCT04440566已完成不适用

O-GlcNAcylation Role in the Pathophysiology of Systemic Lupus Erythematosus

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年10月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Quantification of O-GlcNAcylation level in the blood samples of SLE

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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).

排除标准

  • •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)

研究组 & 干预措施

Systemic lupus erythematosus (SLE)

Experimental

干预措施: blood sample (Biological)

结局指标

主要结局

Quantification of O-GlcNAcylation level in the blood samples of SLE

时间窗: At baseline (Day 0)

次要结局

  • Quantification of OGT biallelic expression in the blood samples of SLE(At baseline (Day 0))
  • Disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)(At baseline (Day 0))
  • Disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004)(At baseline (Day 0))

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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