Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- the cumulative incidence
研究概览
简要总结
Decompensated cirrhosis is associated with sarcopenia. TIPS is an efficient treatment of portal hypertension. Based on our retrospective data, TIPS induces in 30% of cirrhotic patients metabolic disorders associated with diabetes or pre-diabetes. The main objective is to measure the cumulative incidence of diabetes and pre-diabetes 6 months after TIPS insertion.
详细描述
Based on our retrospective data, we expect that one-third of cirrhotic patients develop glucose dysregulation after TIPS. A better knowledge of the metabolic disorders related to the TIPS could allow to prevent the deleterious effects of the TIPS on the disease (decrease of the insulin-sensitivity, fat gain ...), by simple interventions on diet or physical activity. We will assess the incidence of diabetes and pre-diabetes, and the influence of TIPS on nutritional status and sarcopenia. Patients will be follow-up 6 months after TIPS. We will explore the hormonal mechanisms that explain these changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient cirrhosis and portal hypertension justifying a treatment with TIPS
- •written consent.
排除标准
- •contraindication for TIPS
- •indications of TIPS in emergency or as part of the preparation for a surgical procedure,
- •hepatocellular carcinoma outside Milan criteria or cancer at a palliative stage,
- •a contra-indication to the realization of an OGTT,
- •a hyperglycemic treatment (corticosteroids, somatostatin, etc.),
- •hemoglobin <7 g / dl,
- •patients who have had a liver transplant,
- •those for whom the follow-up is considered impossible or the vital prognosis is engaged in the short term,
- •pregnant or lactating women,
- •those unable to receive enlightened information,
- •those participating in interventional research
- •and finally the persons placed under safeguard of justice, tutelage or curatorship.
结局指标
主要结局
the cumulative incidence
时间窗: 6 months
The primary outcome is the cumulative incidence (%) of diabetes and pre-diabetes observed 6 months after TIPS insertion (M6). Diabetes and pre-diabetes will be defined according to World Health Organization (WHO) criteria, based on fasting blood glucose level or 2h after an oral glucose test
次要结局
未报告次要终点