Investigating the Effect of Renin-Angiotensin System Inhibitors in Addition to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Mellitus: A Prospective Open-label Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Serum glycosylated hemoglobin A1c
研究概览
简要总结
Type 2 diabetes mellitus (T2DM) is a progressive metabolic disorder in which a substantial number of patients cannot attain treatment target despite antidiabetic drugs. The renin-angiotensin system (RAS) has recently been implicated in the development of insulin resistance and impaired glucose metabolism. This study investigates the effect of adding RAS inhibitors to standard antidiabetic therapy in patients with T2DM. The primary outcome measure is the change in serum glycosylated hemoglobin A1c after 24 weeks of treatment. Secondary outcomes measures include changes in plasma lipid profile and blood pressure after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults over 21 years of age
- •clinically diagnosed type 2 diabetes mellitus
- •recipients of metformin monotherapy
- •compliance with prescriptions and dietary intervention
排除标准
- •recipients of any second-line antidiabetic drug in addition to metformin
- •recipients of any antihypertensive medication before study enrollment
- •hemoglobin disorders
- •chronic kidney disease
- •thyroid dysfunction
研究组 & 干预措施
Valsartan and metformin
干预措施: Valsartan 80 mg and metformin (Drug)
Metformin only
干预措施: Metformin (Drug)
结局指标
主要结局
Serum glycosylated hemoglobin A1c
时间窗: 24 weeks
Change in serum glycosylated hemoglobin A1c of the participants
次要结局
- Plasma lipid fractions(24 weeks)
- Blood pressure(24 weeks)
研究者
Po-Chung Cheng
Director, Division of endocrine and metabolic diseases
Nantou Christian Hospital