drugset / Trial / NCT03538327

Effects of Silybin in Hypertensive Patients

NCT03538327

Phase 4 Completed 50 enrolled University Magna Graecia
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2013-10
Primary completion
2014-04
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Silymarin Traditional medicine (herbal / TCM) 3 g Oral