Effects of Silybin in Hypertensive Patients

NCT03538327 | Completed Phase 4

• 1 other identifier: UNICZ02
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypertension

Keywords

essential hypertension; insulin resistance; silybin

Outcome Measures

Primary Outcomes (13)

• Improvement in fasting plasma glucose

  Fasting plasma glucose (mg/dL) will be measured after six months of treatment with silybin

  six months after enrollment

• Improvement in 2h post-load plasma glucose

  2h post-load plasma glucose (mg/dL) will be determined after six months of treatment with silybin

  Six months after enrollment

• Improvement in fasting insulin

  Fasting insulin (mU/L) will be measured after six months of treatment with silybin

  Six months after enrollment

• Improvement in total cholesterol

  Total cholesterol (mg/dL) will be measured after six months of treatment with silybin

  Six months after enrollment

• Improvement in HDL cholesterol

  HDL-cholesterol (mg/dL) will be measured after six months of treatment with silybin

  Six months after enrollment

• Improvement in LDL-cholesterol

  LDL-cholesterol (mg/dL) will be measured after six months of treatment with silybin

  Six months after enrollment

• Improvement in clinical SBP

  SBP (mmHg) will be measured after six months of treatment with silybin .

  six months after enrollment

• Improvement in clinical DBP (mmHg)

  DBP (mmHg) will be measured after six months of treatment with silybin

  Six months after enrollment

• Improvement in PP

  PP will be measured after six months of treatment with silybin.

  Six months after enrollment

• Improvement in PWV

  PWV (m/s) will be measured after six months of treatment with silybin

  Six months after enrollment

• Improvement in AI

  AI will be measured after six months of treatment with silybin

  Six months after enrollment

• Improvement in AP

  AP (mmHg) will be measured after six months of treatment with silybin

  Six months after enrollment

• Improvement in serum hs-CRP

  Measurement of serum hs-CRPhs-CRP (mg/dL) will be measured after six moths of treatment with silybin

  Six months after enrollment

Study Arms (1)

Silybin

EXPERIMENTAL

50 Caucasian never-treated hypertensive outpatients, 27 males and 23 women, age range 42-60 years (mean+SD=52+7), showing normal glucose tolerance but 1-h post load plasma glucose \>155 mg/dl, during the OGTT.

Drug: Silybin

Interventions

Silybin DRUG

After enrollment, all patients were encouraged to make lifestyle changes according with current guidelines, moreover it was also recommended to take silybin coniugated to vitamin E and phosphatidylcholine that shows higher intestinal absorption and bioavailability (Indena, IBI-Lorenzini spa Italy: Realsil®), as granules for oral solution at a dose of 3 g bid. Each subject was re-evaluated monthly performing a clinical examination to consider the opportunity of antihypertensive treatment. Finally, inflammatory, metabolic and hemodynamic parameters were assessed after 6 months of treatment. In particular, at the end of the follow-up period, a new OGTT was performed, to test the effects of silybin on glucose tolerance and IR status.

Silybin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Related Publications (1)

• Loguercio C, Festi D. Silybin and the liver: from basic research to clinical practice. World J Gastroenterol. 2011 May 14;17(18):2288-301. doi: 10.3748/wjg.v17.i18.2288.

  PMID: 21633595 BACKGROUND

MeSH Terms

Conditions

Hypertension; Essential Hypertension; Insulin Resistance

Interventions

Silybin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Silymarin; Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Maria Perticone, MD

  Uniersity Magna Graecia of Catanzaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pilot, single arm, interventional, longitudinal study

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: May 29, 2018
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share