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Effects of Silybin in Hypertensive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03538327
Recruitment Status : Completed
First Posted : May 29, 2018
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Perticone, University Magna Graecia

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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: Silybin Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot, single arm, interventional, longitudinal study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Metabolic and Vascular Effects of Silybin in Hypertensive Patients With High One-hour Post-load Plasma Glucose: a Single Arm Pilot Study
Actual Study Start Date : October 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Silybin
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
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.




Primary Outcome Measures :
  1. Improvement in fasting plasma glucose [ Time Frame: six months after enrollment ]
    Fasting plasma glucose (mg/dL) will be measured after six months of treatment with silybin

  2. Improvement in 2h post-load plasma glucose [ Time Frame: Six months after enrollment ]
    2h post-load plasma glucose (mg/dL) will be determined after six months of treatment with silybin

  3. Improvement in fasting insulin [ Time Frame: Six months after enrollment ]
    Fasting insulin (mU/L) will be measured after six months of treatment with silybin

  4. Improvement in total cholesterol [ Time Frame: Six months after enrollment ]
    Total cholesterol (mg/dL) will be measured after six months of treatment with silybin

  5. Improvement in HDL cholesterol [ Time Frame: Six months after enrollment ]
    HDL-cholesterol (mg/dL) will be measured after six months of treatment with silybin

  6. Improvement in LDL-cholesterol [ Time Frame: Six months after enrollment ]
    LDL-cholesterol (mg/dL) will be measured after six months of treatment with silybin

  7. Improvement in clinical SBP [ Time Frame: six months after enrollment ]
    SBP (mmHg) will be measured after six months of treatment with silybin .

  8. Improvement in clinical DBP (mmHg) [ Time Frame: Six months after enrollment ]
    DBP (mmHg) will be measured after six months of treatment with silybin

  9. Improvement in PP [ Time Frame: Six months after enrollment ]
    PP will be measured after six months of treatment with silybin.

  10. Improvement in PWV [ Time Frame: Six months after enrollment ]
    PWV (m/s) will be measured after six months of treatment with silybin

  11. Improvement in AI [ Time Frame: Six months after enrollment ]
    AI will be measured after six months of treatment with silybin

  12. Improvement in AP [ Time Frame: Six months after enrollment ]
    AP (mmHg) will be measured after six months of treatment with silybin

  13. Improvement in serum hs-CRP [ Time Frame: Six months after enrollment ]
    Measurement of serum hs-CRPhs-CRP (mg/dL) will be measured after six moths of treatment with silybin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538327


Sponsors and Collaborators
University Magna Graecia
Investigators
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Principal Investigator: Maria Perticone, MD Uniersity Magna Graecia of Catanzaro

Publications:
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Responsible Party: Maria Perticone, Principal Investigator, University Magna Graecia
ClinicalTrials.gov Identifier: NCT03538327    
Other Study ID Numbers: UNICZ02
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Maria Perticone, University Magna Graecia:
essential hypertension
insulin resistance
silybin
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Silybin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Protective Agents
Physiological Effects of Drugs