ACTRN12609000255280已完成不适用
Randomised, double blind, placebo controlled study to investigate the efficacy of Helicobacter pylori eradication using Esomeprazole, Clarithromycin and Amoxicillin on glucose homeostasis in type 2 diabetes metabolism.
INRCA Hospital0 个研究点目标入组 300 人开始时间: 2009年5月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
入排标准
- 年龄范围
- 35 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Type 2 diabetes.
- •Glycosylated hemoglobin (HbA1c) less than 9.0% at screening.
- •Body Mass Index (BMI) less than 40 kg/m2.
- •Able and willing to give written informed consent and to comply
- •with the requirements of the study.
排除标准
- •Type 1 diabetes.
- •History of ketoacidosis or lactic acidosis.
- •Patients treated with insulin.
- •Patients treated with proton-pump inhibitors.
- •Use of systemic corticosteroids during the last 3 months.
- •History of convulsions and/or epilepsy.
- •Impaired liver function (Alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), total bilirubin or alkaline
- •phosphatase >2.5 x upper limit of normal (ULN)).
- •Myocardial infarction < 6 months before screening.
- •Presence of chronic renal failure.
- •Serious illness, such as active cancer, major active infection, severe
- •psychiatric disorders.
- •Pregnant or lactating women and women with childbearing potential
- •not using adequate method of contraception.
- •Partecipation in a clinical trial with an investigational drug within 3
- •months prior to the screening examination.
研究者
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