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临床试验/NCT05808192
NCT05808192已完成不适用

De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal

University of Rome Tor Vergata1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2020年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
1
主要终点
relation between MS development and IS in LT recipients

研究概览

简要总结

Evaluate de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those taking immunosuppressive therapy ("non-tolerant").

详细描述

A retrospective single-center study was conducted aiming to define the incidence of de novo Metabolic Syndrome (MS) in patients who withdraw Immunosoppression (IS) drugs after Liver Transplant (Tolerant-group) compared to these who couldn't wean IS drugs(non-TOL-group).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
49 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • single LT recipients with an attempt of IS withdrawal
  • minimum 5 years follow-up

排除标准

  • Liver transplant combined with other organs
  • Presence of metabolic syndrome and/or NASH and/or NAFLD as an indication for liver transplantation
  • Loss of patient to follow-up

研究组 & 干预措施

tolerant

patients who withdraw IS drugs after LT

干预措施: Immunosuppressive (Drug)

non tolerant

patients who couldn't wean IS drugs

干预措施: Immunosuppressive (Drug)

结局指标

主要结局

relation between MS development and IS in LT recipients

时间窗: 5 years

Evaluate the de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those who could not withdraw IS ("non-tolerant").

次要结局

  • IS withdrawal in LT recipients(5 years)

研究者

发起方
University of Rome Tor Vergata
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberta Angelico

Professor

University of Rome Tor Vergata

研究点 (1)

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