Hypertension, diabetes, cardiovascular risk Nutritional, Metabolic, Endocrine
Conditions
Interventions
Evaluation at 6 plus or minus 1 week of the cardiovascular and metabolic effects of two different treatments of hypertension: a) continuation of the previous antihypertensive treatment that includes a
Sponsors
University of Palermo (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects 2. Aged 30-80 years 3. Having hypertension for less than 15 years 4. Basal blood pressure <140/90 mmHg 5. Non diabetics or having diabetes for less than 15 years 6. Using at least one of the following diuretics for more than 6 months: furosemide, torasemide, hydrochlorothiazide, chlorthalidone
Exclusion criteria
Exclusion criteria: 1. Average 24 hour blood pressure from ambulatory blood pressure monitoring > 160/90 mmHg 2. Concomitant use of >3 anti-hypertensives 3. Habitual use of indapamide, spironolactone, calcium channel blockers 4. Habitual use of FANS, corticosteroids, litium salts 5. Allergy or intolerance versus calcium-channel blockers 6. Self monitoring average glycemia > 250 mg/dl 7. Glycated hemoglobin > 86 mol/mol 8. Habitual smokers: more than 10 cigarette/day 9. Habitual use of super-alcoholics or wine more than 1 glass/day 10. Secondary hypertension, congestive heart failure, liver cirrhosis, chronic renal failure (calculated -CKEPI, MDRD - GFR< 40 ml/min/1.73 m2) 11. Connective diseases 12. Severe gastro-oesophageal reflux with Barrett's esofagus 13. Atrioventricular conduction defects 14. Pregnancy or lactation in the last six months 15. Denial of informed consent
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Effects on cardiovascular and renal performances: 1. Endothelial function (measured as "flow-mediated dilation") 2. Urinary isoprostanoids 3. Cardiac function evaluated by means of echocardiography, self-monitoring of blood pressure, 24h ambulatory blood pressure monitoring 4. Intra-renal resistances by means of echo-doppler RI (resistance index) and PI (pulsatility index) 5. Creatinine concentrations, calculated Glomerular filtration rate (GFR) [MDRD, Modification of Diet in Renal Disease; CKEPI, Kidney Disease Outcomes Quality Initiative; KDOQI, Chronic Kidney Disease Epidemiology Collaboration] 6. Serum cholesterol, HDL-cholesterol, triglycerides concentrations Outcomes are measured before and 6+/-1 weeks after randomization | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Effects on carbohydrates and uric acid metabolism: Fasting plasma glucose; postprandial glycemia, glycated hemoglobin, glycemia 2h after glucose oral load (75g), 7-day mean glycemia and glycemic variability from continuous subcutaneous glucose monitoring, basal insulinemia, HOMA-I (homeostasis model assessment-index), HOMA-beta, QUICKI (quantitative insulin-sensitivity check index), change in hypoglicemic therapy in diabetics, serum uric acid concentrations. | — |
Countries
Italy
Outcome results
None listed