Effects of Silybin in Hypertensive Patients

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Background: Hypertensive patients with normal glucose tolerance (NGT) but 1-h post load plasma glucose >155 mg/dl (1-h high), during the oral glucose tolerance test (OGTT), show an unfavorable metabolic profile characterized by higher insulin resistance (IR), subclinical inflammation and multiple target organ damage. Experimental and clinical studies have demonstrated that silybin presents important anti-inflammatory and metabolic effects, improving IR and endothelial dysfunction. The present study aims to evaluate the effects of the complex silybin-vitamin E and phospholipids on inflammatory, metabolic and vascular parameters in NGT 1-h high hypertensive patients.

Methods: This is a pilot, single arm, interventional, longitudinal study in which the investigators have planned to enroll 50 Caucasian never-treated hypertensive outpatients, showing normal glucose tolerance but 1-h post load plasma glucose >155 mg/dl, during the OGTT.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Magna Graecia
• Treatments: Silybin; Silymarin

Criteria

Inclusion Criteria:

• Hypertensive NGT patients with 1-h post load plasma glucose >155 mg/dl, during OGTT.

Exclusion Criteria:

• Secondary hypertension

• Ischemic or valvular heart disease

• Congestive heart failure

• Peripheral vascular disease

• Chronic gastrointestinal diseases associated with malabsorption

• Chronic pancreatitis

• History of any malignant or autoimmune disease

• Alcohol or drug abuse

• Liver or kidney failure

• Treatments able to modify glucose metabolism

• Smoking