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临床试验/NCT01461330
NCT01461330终止不适用

Lifestyle Changes in Patients With Type 2 DM and Hypertension: DASH Diet and Exercise Effects

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
40
试验地点
1
主要终点
Change from Baseline in Blood Pressure at 4 weeks

研究概览

简要总结

Data obtained in hypertensive patients without diabetes suggest that increased association of non-pharmacological treatment in patients with diabetes and hypertension may be associated with an improvement in blood pressure control. Despite the beneficial results found, is not yet known the magnitude of the effect of a DASH diet associated with the stimulus of physical activity on BP in patients with type 2 diabetes. The beneficial effects on blood pressure of an additional non-pharmacological intervention to drug therapy may have an even greater impact in patients with treatment-resistant hypertension The aim of this study is to evaluate the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and hypertension resistant to treatment.

详细描述

The aim of this study is to evaluate the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and hypertension. Secondary objectives are: Assess whether the prescription of a DASH-type diet and encouragement for physical activity through use of pedometers, can improve blood pressure control in patients with type 2 diabetes and hypertension resistant to treatment.

Forty type 2 diabetic with resistant hypertension outpatients were included in a randomized clinical trial: treatment 1- DASH diet + encouragement for physical activity through use of pedometer; treatment 2- ADA diet + usual exercises. The duration of each treatment are four weeks. The patients included should have performed Ambulatory Blood Pressure Monitoring (ABPM) to exclude white-coat effect, ie when there are abnormal in the measurement of office blood pressure (equal to or above 140/90 mm Hg) and normal blood pressure by ABPM during the awake period (equal to or below 135/85 mm Hg). Twenty-four hour records with concurrent 24h urinary collections (protein intake estimative), clinical and laboratory evaluation were performed at baseline and after 4 weeks. Serum fatty acids were measured in total lipids by gas chromatography.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • type 2 diabetes
  • Blood pressure ≥140/90 mm Hg
  • ABMP ≥ 135/85 mm Hg

排除标准

  • digestive disease with malabsorption
  • diabetic neuropathy with gastroparesis
  • BMI ≥ 40 kg/m²

结局指标

主要结局

Change from Baseline in Blood Pressure at 4 weeks

时间窗: 4 weeks

Ambulatory Blood Pressure Monitoring (ABPM) at baseline and after 4 weeks

次要结局

  • Change from Baseline in glucose control at 4 weeks(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mirela Jobim de Azevedo

Dr., MD, Associated Professor of Medicine

Hospital de Clinicas de Porto Alegre

研究点 (1)

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