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临床试验/NCT06372015
NCT06372015招募中不适用

Changes in the Lipidomic, Immunological and Circulating microRNA Profile in Patients With Hepatobiliary Pathology, Suffering From Morbid Obesity Undergoing a Dietary Program or Bariatric Surgery

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis

研究概览

简要总结

Obesity is a chronic disease characterized phenotypically by an increase in body weight (BMI>30 kg/m2) and by a series of associated pathologies, such as hypertension, diabetes, hepatic steatosis.

The association of these pathologies compromises the patient's survival and quality of life. The multifactorial origin of obesity makes its etiopathology difficult to manage. It is often possible to follow only one therapeutic strategy, especially after the so-called standard treatments, such as dietary intervention and physical activity, have not brought benefit to the patient. In these cases, an appropriate treatment for the patient to enjoy significant weight loss is bariatric surgery.

Bariatric surgery refers to all those interventions aimed at reducing weight in those suffering from obesity, and treating the diseases associated with it.

Among the different types of bariatric surgery, the techniques most used in common clinical practice are intragastric balloons, gastric by pass (RYGB) and sleeve gastrectomy.

The choice of the surgeon, assisted by the multidisciplinary team, is binding in the choice of the type of operation to which the patient will be subjected.

详细描述

Obesity is a chronic disease characterized phenotypically by an increase in body weight (BMI>30 kg/m2) and by a series of associated pathologies, such as hypertension, diabetes, hepatic steatosis.

The association of these pathologies compromises the patient's survival and quality of life. The multifactorial origin of obesity makes its etiopathology difficult to manage. It is often possible to follow only one therapeutic strategy, especially after the so-called standard treatments, such as dietary intervention and physical activity, have not brought benefit to the patient. In these cases, an appropriate treatment for the patient to enjoy significant weight loss is bariatric surgery.

Bariatric surgery refers to all those interventions aimed at reducing weight in those suffering from obesity, and treating the diseases associated with it.

Among the different types of bariatric surgery, the techniques most used in common clinical practice are intragastric balloons, gastric by pass (RYGB) and sleeve gastrectomy.

In our institution, the diagnostic therapeutic care path for the integrated treatment of obese patients (P.D.T.A) is regulated by DDG n. 528 of 10/27/2022, which indicates the path that the patient must follow if he decides to evaluate a Bariatric Surgery procedure.

研究设计

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

入排标准

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

入选标准

  • Obese patients (BMI >30kg/m2) suffering from hepato-biliary pathology diagnosed by Fibroscan
  • Adult patients (>18 years).

排除标准

  • Patients who are not obese or not affected by hepato-biliary pathology

结局指标

主要结局

The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis

时间窗: at Baseline and at 1 year

Evaluate how bariatric surgery affects routine blood chemistry parameters. The following will be taken into consideration: Blood sugar, Glycated hemoglobin, triglycerides, total cholesterol, HDL and LDL, transaminases, γGT, creatinine, uric acid

Variation of lipidomic parameters

时间窗: at Baseline and at 1 year

Variation of lipidomic parameters measured by extraction of fatty acids from red blood cells and run in gas chromatography

Variation in the microRNA profile

时间窗: at Baseline and at 1 year

Evaluation of microRNA profile change by real-time PCR

次要结局

未报告次要终点

研究者

发起方
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Rossella Donghia

Biologyst

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

研究点 (1)

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