Evaluation of Effects of Exercise Training and ARB in DM Patients
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Purpose
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 | Intervention |
|---|---|
|
Vascular Function Exercise Training |
Drug: olmesartan |
| Study Type: | Observational |
| Study Design: | 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 |
- 1. Vascular function testing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Exercise capacity testing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Circulating biomarkers including hs-CRP, adiponectin, myostatin, MMP, etc [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
serum
| Enrollment: | 15 |
| Study Start Date: | December 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
-
Drug: olmesartan
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.
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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)
Contacts and Locations| Taiwan | |
| National Taiwan University Hospital | |
| Taipei, Taiwan, 100 | |
| Principal Investigator: | Yen-Wen Wu, MD, PhD | National Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01053026 History of Changes |
| Other Study ID Numbers: | 200903006R |
| Study First Received: | January 18, 2010 |
| Last Updated: | November 15, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Angiotensin receptor II antagonist |
Additional relevant MeSH terms:
|
Olmesartan Olmesartan medoxomil Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013