Evaluation of Effects of Exercise Training and ARB in DM Patients

Exercise Training Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053026
• Other study ID #: 200903006R
• Status: Completed
• Phase: N/A
• First received: January 18, 2010
• Last updated: November 15, 2012
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exercise Training
• Vascular Function

Intervention

Drug:
• olmesartan
(1) Olmesartan treatment or (2) Life modification and exercise training

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Daiichi Sankyo Taiwan Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Vascular function testing		12 weeks	No
Secondary	Exercise capacity testing		12 weeks	No
Secondary	Circulating biomarkers including hs-CRP, adiponectin, myostatin, MMP, etc		12 weeks	No