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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01053026
Enrollment
15
Registered
2010-01-21
Start date
2009-12-31
Completion date
2011-12-31
Last updated
2012-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Training, Vascular Function

Keywords

Angiotensin receptor II antagonist

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.

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.

Interventions

DRUGolmesartan

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

Sponsors

Daiichi Sankyo Taiwan Ltd.
CollaboratorINDUSTRY
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
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)

Design outcomes

Primary

MeasureTime frame
1. Vascular function testing12 weeks

Secondary

MeasureTime frame
Exercise capacity testing12 weeks
Circulating biomarkers including hs-CRP, adiponectin, myostatin, MMP, etc12 weeks

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026