Change of Lifestyle in Elderly Patients With Type 2 Diabetes and Systemic Arterial Hypertension: Effects of DASH Diet and Physical Activity on Blood Pressure and Insulin Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change from Baseline Blood Pressure at 4 months
研究概览
简要总结
Evaluate the effect of lifestyle modification through the adoption of a DASH diet, with and without physical activity guidance, on blood pressure and insulin sensitivity in elderly patients with type 2 diabetes and hypertension.
详细描述
Data regarding the effects of physical activity and DASH-type diet on blood pressure control in patients with type 2 diabetes and hypertension are scarce in the literature, whether evaluating these isolated interventions or together. In addition, most studies do not measure BP using ABPM, which has a special importance in the assessment of pressure homeostasis in DM or are short-term studies. Were only two studies have been identified in the literature that evaluated the effect of the DASH diet on patients with type 2 DM; however, in both trials, being elderly was not an inclusion criterion. The first was an Iranian study that demonstrated in 31 non-hypertensive patients a significant reduction in BP after 8 weeks of following a DASH diet. In the second ECR, we demonstrated that in 20 hypertensive type 2 DM patients, all using antihypertensive drugs and with uncontrolled BP, a DASH-type diet for 4 weeks associated with physical activity reduced the systolic BP assessed by ABPM by 12.5 mmHg. However, the adopted design did not allow to separate the effect of diet from the effect of physical activity. On the other hand, the effect of a single session of walking followed by a 24-hour ABPM assessment showed a reduction in BP in hypertensive elderly and non-hypertensive patients, also without DM. So far it is not defined in patients with type 2 DM and hypertension, especially the elderly, whether the DASH diet alone is as beneficial for BP as its association with physical activity, particularly, considering the difficulties of performing exercises in this group of patients. This is valuable information, as it would reinforce the role of diet therapy intervention even if in isolation in this age group. Furthermore, the role of the DASH diet with or without physical activity remains unknown on insulin sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 years or more
- •Diabetes Mellitus
- •Hypertension with poor control
排除标准
- •Glucocorticoid use
- •Unstable angina
- •Acute myocardial infarction in the last 6 months
- •Heart failure classes III and IV
- •history of cirrhosis, alcoholism or use of illicit drugs
- •Dementia and malignant disease that compromises survival in 5 years
- •Serum creatinine greater than 2, 0mg / dl
- •BMI> 40 kg / m²
- •Physical disability that prevents the use of a pedometer
- •Participating in another research project involving any type of intervention.
结局指标
主要结局
Change from Baseline Blood Pressure at 4 months
时间窗: Baseline and 4 months
24 hours ambulatory blood pressure monitoring (ABPM)
次要结局
- Change from Baseline Insulin Sensitivity at 4 months(Baseline and 4 months)
- Change from Baseline Skeletal muscle mass at 4 months(Baseline and 4 months)
- Change from Baseline Total cholesterol at 4 months(Baseline and 4 months)
- Change from Baseline Triglycerides at 4 months(Baseline and 4 months)
- Change from Baseline Percent body Fat at 4 months(Baseline and 4 months)
- Change from Baseline HDL cholesterol at 4 months(Baseline and 4 months)
- Change from Baseline Glucose Profile at 4 months(Baseline and 4 months)
- Change from Baseline Body fat mass at 4 months(Baseline and 4 months)
- Change from Baseline Weight at 4 months anthropometric variables(Baseline and 4 months)
- Change from Baseline BMI at 4 months(Baseline and 4 months)
- Change from Baseline LDL cholesterol at 4 months(Baseline and 4 months)
