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临床试验/NCT01053026
NCT01053026已完成不适用

Evaluation of Vascular Function, Effects of Exercise Training and Angiotensin Receptor II Antagonist in Patients With Type II Diabetes and Hypertension by Using Near-infrared Spectroscopy, Rapid Laser Doppler Blood Flow Imaging and Circulating Biomarkers

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年12月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
1. Vascular function testing

研究概览

简要总结

The aims of this clinical trial are to assess the impacts on vascular function tests and circulating biomarkers of a short-term (12-week) low-to-median intensity exercise training or ARBs treatment in patients with DM and hypertension.

详细描述

Inclusion criteria: type II diabetic and hypertensive patients who are aged 30 to 70 year-old with HbA1c ≤ 8.0 % and systolic blood pressure ≥ 140 mmHg. Neither ACEI nor ARB is administrated in recent 6 months. None has significant concomitant systemic diseases such as active infection, malignancy, hepatic or significant renal dysfunction at the time of enrollment (i.e. total bilirubin > 3 mg/dl,ALT > 2.5 times the upper limit of normal range and creatinine > 3 mg/dl in our hospital). Information regarding smoking, hypertension, hyperlipidemia as well as history of cardiovascular disease is obtained from all subjects. No other medication will be modified during the study period. After enrollment, patients are assessed to (1) olmesartan (20 mg per day, with titration), (2) life modification/exercise training for 12 weeks. Vascular function and exercise capacity studies, and peripheral blood testing are performed at baseline and at 12- week follow-up. Data are collected as mean ± SD showing comparison between groups by use of 2-sample t test and chi-square analysis for continuous and categorical variables, respectively. Adjust for the HbA1c level will be adjusted using simple adjustment method (ANCOVA or equivalent regression analysis) while doing the data analysis. Changes between baseline and follow-up measurements are assessed by paired t test. The frequencies of adverse effects between groups will also be comparing by 2-sample t test. A p value <0.05 is defined as statistically significant.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with diabetes mellitus and hypertension
  • age 30-70 years,systolic blood pressure 140-160 mmHg and HbA1c ≤ 8%,
  • no history of ACEI or ARB use within 6 months

排除标准

  • active cardiovascular diseases
  • severe hepatic
  • renal dysfunction (CRE ≥ 3 mg/dl,T-Bil ≥ 3 mg/dl)

结局指标

主要结局

1. Vascular function testing

时间窗: 12 weeks

次要结局

  • Exercise capacity testing(12 weeks)
  • Circulating biomarkers including hs-CRP, adiponectin, myostatin, MMP, etc(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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