Hypertension Clinical Trial
Official title:
Metabolic and Vascular Effects of Silybin in Hypertensive Patients With High One-hour Post-load Plasma Glucose: a Single Arm Pilot Study
NCT number | NCT03538327 |
Other study ID # | UNICZ02 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | May 2014 |
Verified date | May 2018 |
Source | University Magna Graecia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Magna Graecia |
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in fasting plasma glucose | Fasting plasma glucose (mg/dL) will be measured after six months of treatment with silybin | six months after enrollment | |
Primary | 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 | |
Primary | Improvement in fasting insulin | Fasting insulin (mU/L) will be measured after six months of treatment with silybin | Six months after enrollment | |
Primary | Improvement in total cholesterol | Total cholesterol (mg/dL) will be measured after six months of treatment with silybin | Six months after enrollment | |
Primary | Improvement in HDL cholesterol | HDL-cholesterol (mg/dL) will be measured after six months of treatment with silybin | Six months after enrollment | |
Primary | Improvement in LDL-cholesterol | LDL-cholesterol (mg/dL) will be measured after six months of treatment with silybin | Six months after enrollment | |
Primary | Improvement in clinical SBP | SBP (mmHg) will be measured after six months of treatment with silybin . | six months after enrollment | |
Primary | Improvement in clinical DBP (mmHg) | DBP (mmHg) will be measured after six months of treatment with silybin | Six months after enrollment | |
Primary | Improvement in PP | PP will be measured after six months of treatment with silybin. | Six months after enrollment | |
Primary | Improvement in PWV | PWV (m/s) will be measured after six months of treatment with silybin | Six months after enrollment | |
Primary | Improvement in AI | AI will be measured after six months of treatment with silybin | Six months after enrollment | |
Primary | Improvement in AP | AP (mmHg) will be measured after six months of treatment with silybin | Six months after enrollment | |
Primary | 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 |
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