White Blood Cells Gene Expression Profiles as a Tool for Predicting Metformin Efficacy in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Fasting glucose change after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells
研究概览
简要总结
Our general aim is to investigate whether messenger RNA (mRNA) and/or microRNA (miRNA) expression profiles in white blood cells, predict metformin monotherapy efficacy in patients with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes (duration of diabetes of at least 2 years)
- •age 40-70 yrs
- •HbA1c > 6.4 < 9.0
排除标准
- •insulin therapy
- •contraindications to metformin use
研究组 & 干预措施
Metformin
At study entry, all oral hypoglycemic agents will be discontinued for 5 days and then metformin (2,550 mg/daily) will be given for 3 months. Fasting plasma glucose will be measured at baseline and 3 months after metformin treatment. Patients will be stratified according to the median value of metformin efficacy as indicated by fasting glucose change after metformin treatment (i.e. baseline fasting glucose minus 3-month fasting glucose).
So, two subgroups of patients will be obtained, defined as relatively "high responders" (individual fasting glucose change > median value) or relatively "low responders" (individual fasting glucose change < median value) to metformin monotherapy.
干预措施: Metformin (Drug)
结局指标
主要结局
Fasting glucose change after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells
时间窗: Baseline and after three months of metfomin therapy
Changes in fasting glucose levels will be used to evaluate if metformin monotherapy efficacy in type 2 diabetic patients is predicted by mRNA and/or miRNA expression profiles. Please note that metformin major effect is to decrease hepatic glucose output and, therefore, to lower fasting plasma glucose which is, in fact, the clinical outcome used in this study. Finally, because of a very short wash-out period (i.e. 5 days) we will not be able to use HbA1c which will be inevitably conditioned by previous oral hypoglicemic therapy.
次要结局
- Change in fasting insulin levels after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells(Baseline and after three months of metfomin therapy)