Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- glucose control
研究概览
简要总结
Aim:
The purpose of this study is to compare the effects of glimepiride(G) and metformin(M) on vascular reactivity, haemostatic factors and glucose and lipid profile in patients with type 2 diabetes.
Methods:
A prospective study will be performed in 20 uncontrolled patients previously treated with dietary intervention. Participants will randomized into M (750 to 2500 mg/day) or G (1 to 8 mg/day) therapy. After 4 months, the patients will be crossed-over with no washout period to the alternative treatment for an additional 4-month period on similar dosage schedule.
- The following variables were assessed before (basal values) and after 4 months of each treatment period:
- Hormonal and metabolic determinations: fasting plasma glucose, insulin, catecholamine, lipid profile and HbA1 levels.
- Haemostatic factors: t-PA antigen and activity, PAI-1 antigen and activity, platelet aggregation, fibrinogen and plasminogen levels.
- Cardiovascular evaluation: flow indexes of carotid and brachial arteries. Also, at the end of each treatment period, a 12-hour metabolic profile including measurements of glucose, insulin, glucagon, proinsulin and triglycerides levels at fasting and every 2 hours (7:00 am to 7:00 pm)will be done
详细描述
Measurements were be made at fasting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 patients with fasting glucose values >7.78 mmol/L and/or glycated hemoglobin exceeding 1.0% or more the normal range (4-8.5%) after 2 or more months of a diet therapy
排除标准
- •any severe concomitant illness
- •nephropathy (serum creatinine >1.6 mg/dL and microalbuminuria)
- •uncontrolled hypertension (BP >190x120 mmHg)
- •peripheral vascular disease
- •marked dyslipidemia (total cholesterol>6.5mM/L and triglycerides levels >2.8mM/L)
- •coagulopathy
- •proliferative retinopathy and use of hypolipemic and anticoagulant medications or autonomic neuropathy
- •assessed by blood pressure response to standing
- •beat-to -beat heart rate variation
- •Valsalva maneuver and handgrip test.
研究组 & 干预措施
metformin
Participants will randomized into Metformin (750 to 2500 mg/day) or Glimepiride (1 to 8 mg/day) therapy. After 4 months, the patients will crossed-over with no washout period to the alternative treatment for an additional 4-month period on similar dosage schedule
干预措施: Metformin (Drug)
glimepiride
Participants will randomized into Metformin (750 to 2500 mg/day) or Glimepiride (1 to 8 mg/day) therapy. After 4 months, the patients will crossed-over with no washout period to the alternative treatment for an additional 4-month period on similar dosage schedule
干预措施: Glimepiride (Drug)
结局指标
主要结局
glucose control
时间窗: every 2 weeks
measurements of glucose , glycated haemoglobin and insulin levels
次要结局
- haemodynamic improvement(every 4 months)
研究者
Maria Elizabeth Rossi da Silva
Principal Investigator
University of Sao Paulo