Assessment of Feasibility and Efficacy of a Project Aimed to Improve Metabolic Control in Type 2 Diabetes Through Lifestyle Changes and Self-monitoring of Blood Glucose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 主要终点
- Change in haemoglobin A1c (HbA1c) levels
研究概览
简要总结
The purpose of the study is to evaluate the impact of an exercise programme organized into supervised walking groups on metabolic control, functional capacity and overall quantity of physical activity in subjects with type 2 diabetes.
详细描述
Regular, moderate-intensity physical activity can attenuate hyperglycemia in subjects with type 2 diabetes. In addition, these programmes may favourably affect several other cardiovascular risk factors in these subjects. However, it still remains unclear how this evidence can be transferred into clinical practice, considering the very large number of diabetic patients and the characteristics of this population, made up predominantly of elderly, sedentary and overweight patients. In this regard, a realistic approach to this issue requires simple and easily available intervention models.
Walking is a typical mild-moderate aerobic physical activity which is easy to organize and does not require specific skills or preliminary sophisticated medical evaluations. This activity could therefore fit well with the need of involvement of large numbers of patients in different logistic situations. However, it has been reported that, due to the low walking speed typical of type 2 diabetic subjects, self-paced walking is inadequate to obtain a significant metabolic improvement in these subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetes known for at least 2 yr
- •physical inactivity
- •haemoglobin (Hb)A1c between 6.5-9.9%
- •treatment with oral hypoglycaemic agents alone or associated with a bed-time insulin injection
- •willingness to participate in a programme of regular physical activity
排除标准
- •moderate-severe autonomic or somatic neuropathy
- •severe lower limb vasculopathy
- •pre-proliferative or proliferative active retinopathy
- •moderate to severe chronic renal failure
- •unstable angina or recent (in the previous 3 months) myocardial infarction
- •acute intercurrent diseases
- •acute metabolic decompensation (blood glucose >300 mg/dl or ketonuria in two consecutive checks)
- •use of beta-blocker drugs
- •subjects unable to complete a 6-min walk test
结局指标
主要结局
Change in haemoglobin A1c (HbA1c) levels
时间窗: 4 months
The measurement of HbA1c is carried out with a DCCT-aligned method.
次要结局
- Change in Blood Pressure(4 months)
- Change in Fasting plasma glucose levels(4 months)
- Change in HDL Cholesterol levels(4 months)
- Change in Total Cholesterol levels(4 months)
- Change in Antidiabetic medications(4 months)
- Change in Body weight(4 months)
- Change in Energy expenditure through voluntary physical activity(4 months)
- Change in LDL Cholesterol levels(4 months)
- Change in Triglycerides levels(4 months)
- Change in 6 minutes walk distance(4 months)
- Change in C-reactive protein levels(4 months)
- Compliance with walking sessions(4 months)