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临床试验/NCT05988346
NCT05988346已完成不适用

Ghrelin Expression Could Regulate Diastolic Heart Function in Obese Patients With Diabetes

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
normalization of LV diastolic dysfunction

研究概览

简要总结

In type 2 diabetes mellitus (T2DM) and obese patients the adipose tissue could over-express cytokines, sirtuin-1 (SIRT1), and microRNAs (miRs) implied in the regulation of left ventricle (LV) diastolic function (LV-DF). Ghrelin could modulate these pathways. Thus, in the current study authors will investigate ghrelin expression in T2DM obese patients after abdominal fat excision, and particularly in those with normalization of LV-DF at 1 year of follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of T2DM obese patients;
  • T2DM obese patients under anti-diabetic full medical therapy and glycemic control.

排除标准

  • clinical diagnosis of type 1 diabetes;
  • T2DM patients in poor glycemic control (HbA1c values of >7%);
  • chronic neurological disorders;
  • heart failure and coronary heart disease or depression of left ventricular ejection fraction (LVEF <55%);
  • severe anemia;
  • thyroid dysfunction;
  • kidney failure;
  • uncontrolled blood pressure (blood pressure > 140/90 mmHg on two occasions 2 weeks apart);
  • inflammatory chronic disease;
  • neoplastic disease.

结局指标

主要结局

normalization of LV diastolic dysfunction

时间窗: 12 months

At 1 year of follow-up authors evaluated the patients (those with first and second degree of LV diastolic dysfunction) that will experience the normalization of LV diastolic function.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Celestino Sardu

Professor of Medicine

University of Campania "Luigi Vanvitelli"

研究点 (1)

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