Evaluation of Effects of Exercise Training and ARB in DM Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01053026
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : November 16, 2012
Daiichi Sankyo Taiwan Ltd.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Vascular Function Exercise Training 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
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 : December 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 1. Vascular function testing [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Exercise capacity testing [ Time Frame: 12 weeks ]
  2. Circulating biomarkers including hs-CRP, adiponectin, myostatin, MMP, etc [ Time Frame: 12 weeks ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with diabetes melitus and hypertension

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01053026

National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Daiichi Sankyo Taiwan Ltd.
Principal Investigator: Yen-Wen Wu, MD, PhD National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital Identifier: NCT01053026     History of Changes
Other Study ID Numbers: 200903006R
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: November 16, 2012
Last Verified: July 2012

Keywords provided by National Taiwan University Hospital:
Angiotensin receptor II antagonist

Additional relevant MeSH terms:
Olmesartan Medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action