Evaluation of Effects of Exercise Training and ARB in DM Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Exercise Training; Vascular Function
• Intervention / Treatment: Drug: olmesartan

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with diabetes melitus and hypertension

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1. Vascular function testing	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Exercise capacity testing	12 weeks
Circulating biomarkers including hs-CRP, adiponectin, myostatin, MMP, etc	12 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Daiichi Sankyo Taiwan Ltd.
• Investigators: Principal Investigator: Yen-Wen Wu, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: January 18, 2010
• First Submitted That Met QC Criteria: January 20, 2010
• First Posted (Estimate): January 21, 2010

Study Record Updates

• Last Update Posted (Estimate): November 16, 2012
• Last Update Submitted That Met QC Criteria: November 15, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Angiotensin receptor II antagonist
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Olmesartan
• Other Study ID Numbers: 200903006R