Evaluation of Effects of Exercise Training and ARB in DM Patients

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01053026
Collaborator
Daiichi Sankyo Taiwan Ltd. (Industry)
15
1
24
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
15 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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
Study Start Date :
Dec 1, 2009
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Outcome Measures

Primary Outcome Measures

  1. 1. Vascular function testing [12 weeks]

Secondary Outcome Measures

  1. Exercise capacity testing [12 weeks]

  2. Circulating biomarkers including hs-CRP, adiponectin, myostatin, MMP, etc [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital
  • Daiichi Sankyo Taiwan Ltd.

Investigators

  • Principal Investigator: Yen-Wen Wu, MD, PhD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01053026
Other Study ID Numbers:
  • 200903006R
First Posted:
Jan 21, 2010
Last Update Posted:
Nov 16, 2012
Last Verified:
Jul 1, 2012
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2012