Evaluation of Effects of Exercise Training and ARB in DM Patients

Completed

• Conditions: Vascular Function; Exercise Training

• Registration Number: NCT01053026
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-18
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-11-15
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Vascular function testing	12 weeks

Secondary Outcome Measures

Name	Time	Method
Exercise capacity testing	12 weeks
Circulating biomarkers including hs-CRP, adiponectin, myostatin, MMP, etc	12 weeks

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan