Prospective, randomized, open-label,clinical trial comparing the effects of hydrogen tablet and placebo on blood and urine makers for cardiovascular diseases
Not Applicable
- Conditions
- cardiovascular disease, diabetes and dyslipidemia
- Registration Number
- JPRN-UMIN000032701
- Lead Sponsor
- Tokorozawa Heart Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) Poor-controlled hypertension (DBP>110) 2) Poor-controlled diabetes (HbA1c>8.0 %) 3) Secondary hypertension 4) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 5) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 6) End stage renal disease 7) Symptomatic (NYHA III or IV) congestive heart failure 8) Malignancies or other diseases with poor prognosis 9) Subjects whose doctor in charge do not agree to join the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Markers indicating oxidative stress (Oxidized albumin, isoprostane, 8-OHdG, MDA-LDL, FABP) 4 weeks after administration
- Secondary Outcome Measures
Name Time Method Blood lipids, glucose, HbA1c Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), and early-staged kidney diseases (microalbuminuria) 4 weeks after administration