Diuretics and Diabetes Control: DIaDIC study

Completed

Conditions: Hypertension, diabetes, cardiovascular risk
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN03504931

Lead Sponsor: niversity of Palermo (Italy)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Effects on carbohydrates and uric acid metabolism:<br>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.

Secondary Outcome Measures

Name	Time	Method
Effects on cardiovascular and renal performances:<br>1. Endothelial function (measured as flow-mediated dilation)<br>2. Urinary isoprostanoids<br>3. Cardiac function evaluated by means of echocardiography, self-monitoring of blood pressure, 24h ambulatory blood pressure monitoring<br>4. Intra-renal resistances by means of echo-doppler RI (resistance index) and PI (pulsatility index)<br>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]<br>6. Serum cholesterol, HDL-cholesterol, triglycerides concentrations<br>Outcomes are measured before and 6+/-1 weeks after randomization