Table 1.

Selection criteria

Inclusion criteria
• Men and women older than 18 years of age.
• Waist circumference ≥ 90 cm in male and ≥ 80 cm in female.
• To have fasting plasma glucose between 100 and 125 mg/dL and/or OGTT at 2 hours ≥ 140 mg/dL and <200 mg mg/dL.
• Having a treatment compliance over 80% at the end of the run-in phase.
All women with bearing potential must have a secure contraceptive method. Secure method will be considered: surgical sterilization, postmenopause condition with an age greater than 45 years and a period of amenorrhea ≥ 2 years. (In premenopausal women, the use of hormonal method or two barrier contraceptive methods including 1 month after the conclusion of the active phase of study treatment).
Exclusion criteria
• Prior diagnosis of type 1 or 2 diabetes mellitus, chronic or acute renal insufficiency, coronary disease clinically evident (acute myocardial infarction, chest angina, myocardial revascularization) or cardiac insufficiency, or history of prior cardiovascular events (AMI, CVD, or CABG).
• Significant chronic disease (terminal stage cirrhosis or hepatic disease or cancer) that affects the survival of patients at 24 months.
• Chronic inflammatory diseases except obesity (lupus, rheumatoid arthritis, etc.).
• Blood arterial pressure >140/90.
• Acute infection of any etiology within 4 weeks prior to the beginning of the study.
• Use of steroid hormones or NSAIDs 4 weeks prior to the beginning of the study.
• Patient enrolled in a program or treatment to lose weight, 8 weeks prior to the study entry.
• Patient requiring treatment with immunosuppressive agents, for any circumstance.
• Patient who has participated in a clinical trial in the 8 weeks prior to the study entry.
• Patient who requires a major surgical procedure during the next 12 months, after enrollment (Abdominal or thoracic surgery, vascular, neurosurgery, urologic or gynecologic surgical procedure).
• Patient with history of severe chronic gastritis or any condition of the gastrointestinal tract that may affect the absorption and/or distribution of any drug administered orally.
• Alteration of the hepatic function tests.
• Triglycerides ≥ 600 mg%.
• Serum creatinin ≥ 1.5 mg/dl or calculated creatinin clearance (Cockroft's method) less than 50 ml/min.
• History of use of psychoactive drugs or abuse of alcohol.
• Positive pregnancy test in the screening visit.
• Concomitant treatment with any other antihypertensive drug.
• Contraindication to receive treatment with Candesartan.
• Pathological alterations of aortic or mitral cardiac valves (stenosis o insufficiency) or hypertrophy cardiomyopathy.
• Denial to sign informed consent, or any mental condition that makes the patient part of a susceptible population