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Completed

NCT Number: NCT01053026

Evaluation of Effects of Exercise Training and ARB in DM Patients

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan, 100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Olmesartan

Drug

(1) Olmesartan treatment or (2) Life modification and exercise training

Primary outcomes

  1. 1. Vascular function testing

    Time frame: 12 weeks

Secondary outcomes

  1. Exercise capacity testing

    Time frame: 12 weeks

  2. Circulating biomarkers including hs-CRP, adiponectin, myostatin, MMP, etc

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Daiichi Sankyo Taiwan Ltd.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 21, 2010
Registry last updated
Nov 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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