Therapeutic Strategies of Prevention of Diabetes and Hypertension in Subjects with Metabolic Syndrome and High-Normal Blood Pressure. - PHIDIAS

Conditions: Hypertension, diabetes mellitus.
MedDRA version: 6.1Level: SOCClassification code 10007541

Registration Number: EUCTR2007-000947-88-IT

Lead Sponsor: ISTITUTO AUXOLOGICO ITALIANO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 6000

Inclusion Criteria

Inclusion criteria - Men or women of any racial background - Age 40 years and 75 years - SBP 130 mmHg and 140 mmHg or DBP 85 mmHg and 90 mmHg, average of screening and randomisation visits in absence of any antihypertensive medication - FG 100 mg/dl 5.6 mmol/l and 126 mg/dl 7.0 mmol/l between screening and randomisation in absence of any antidiabetic medication - Waist circumference 102 cm in men and 88 cm in women
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- SBP 140 mmHg or DBP 90 mmHg - Any antihypertensive, antidiabetic or antiobesity medication at the time of or during the 6 months previous to randomisation - Any current or previous cardiovascular or renal disease requiring continuous administration of Ds, Bs, ACEIs, ARBs, CAs, and any other antihypertensive medication - Any medical condition preventing adherence to lifestyle measures included in the protocol - Hepatic disease as AST SGOT or ALT SGPT values equal or greater than two times the upper limit of normal - Chronic renal dysfunction as serum creatinine 2.0 mg/dl - Any gastrointestinal disorder interfering with drug absorption - Known allergy or contraindications to ACEIs or ARBs - Pregnant or lactating women; women in reproductive age not using recognized contraceptive methods - Malignancy within the last 5 years - Clinically significant autoimmune disorders - Drug abuse or alcohol abuse within the last 5 years - History of noncompliance to medical regimens - Incapacity or unwillingness to sign the informed consent - Participation in any investigational clinical trial within the last 3 months