Compliance With Dietary Recommendations in Obese Diabetic Patients Undergoing Acarbose Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 423
- 主要终点
- Change in HbA1c value between initial and final visit
研究概览
简要总结
It has been recently suggested, that not the diet by itself, but also patient's adherence to dietary recommendations and all actions performed to improve dietary compliance, may be a significant factor influencing blood glucose control. There are no clinical data on the influence of different approaches to dietary advising on the effects of acarbose treatment in obese diabetic patients under real-life setting in Poland. Thus, the aim of this study was to assess the influence of different approaches to dietary advisory on the effects of acarbose treatment (reflected by changes in HbA1c) in obese DM patients. We also intended to assess the influence of different approaches to dietary advising on the appearance of potential adverse events in acarbose treated obese DM patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •age>18 years
排除标准
- •Hypersensitivity to acarbose or any of the excipients
- •pregnancy and in nursing
- •inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction
- •chronic intestinal diseases associated with marked disorders of digestion or absorption
- •states which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld's syndrome [an angina pectoris-like syndrome or aggravation of an angina pectoris due to the post-prandial filling of the stomach] and larger hernias)
- •hepatic and severe renal impairment (creatinine clearance <25 mL/min/ 1,73m2)
研究组 & 干预措施
Group 1
干预措施: Glucobay (Acarbose, BAYG5421) (Drug)
结局指标
主要结局
Change in HbA1c value between initial and final visit
时间窗: approx. 3 mths after acarbose treatment initiation
次要结局
- Number of participants with adverse events in both study groups. The influence of different approaches to dietary advising on the appearance of adverse events.(approx 3 mths after acarbose treatment initiation)