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临床试验/NCT01963130
NCT01963130已完成不适用

Does Vildagliptin Affect Portal Vein Pressure In Patients With Type 2 Diabetes Mellitus? A Cross Sectional Study

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
1
主要终点
This study investigated the effect of the used type 2 DM drug, vildagliptin, a DPP-4 inhibitor, on portal hemodynamics.

研究概览

简要总结

This study investigated how vildagliptin (a di-peptidyl peptidase 4 inhibitor) affects portal vein pressure and hepatosteatosis in patients with type 2 diabetes mellitus.

详细描述

Group 1 used metformin (1000 mg bid) and gliclazide (60 mg qd); Group 2 used the same amounts of metformin and gliclazide, with the addition of vildagliptin (50 mg bid). The patients were prospectively assigned to each of these two groups for the purpose of this study. Using Doppler ultrasound, all cases were measured for portal vein flow velocity, portal vein flow and portal vein diameter. Degree of hepatosteatosis was also recorded.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • type 2 DM cases and at least 3 months used the same drugs (metformin and gliclazide or metformin and gliclazide and vildagliptin)

排除标准

  • used alcohol and cigarettes
  • chronic liver disease,
  • chronic renal failure,
  • active infection
  • patients using certain drugs which may affect portal pressure such as propronalol,
  • calcium channel blockers,
  • angiotensin-converting enzyme inhibitors,
  • angiotensin receptor blockers and isosorbit monohydrate

结局指标

主要结局

This study investigated the effect of the used type 2 DM drug, vildagliptin, a DPP-4 inhibitor, on portal hemodynamics.

时间窗: at least 3 month (mean 7.8 months)

This study investigated how vildagliptin (a di-peptidyl peptidase 4 inhibitor) affects portal vein pressure in patients with type 2 diabetes mellitus. Portal vein flow velocity, portal vein flow, and portal vein diameter of all cases were measured by Doppler ultrasound in both groups.

次要结局

  • This study investigated the effect of the used type 2 DM drug, vildagliptin, a DPP-4 inhibitor, on hepatosteatosis.(followed for at least 3 months (mean 7.8 months))

研究者

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

Cumali Karatoprak

MD

Bezmialem Vakif University

研究点 (1)

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