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.

Hypertension

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

Effects of Silybin in Hypertensive Patients

Metabolic and Vascular Effects of Silybin in Hypertensive Patients With High One-hour Post-load Plasma Glucose: a Single Arm Pilot Study

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

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

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

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

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

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

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

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

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

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

AI will be measured after six months of treatment with silybin

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

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

Maria Perticone

Principal Investigator

University Magna Graecia

Pilot, single arm, interventional, longitudinal study

ER Niacin (Niaspan) 2000mg one hour prior to Oral Fat Challenge using fresh cream at a dose of 50 g fat per square meter of body surface area. This is followed by frequent plasma and urine collections for next 12 hours to assess markers of fat metabolism and inflammation.

Immediate-Release Niacin (Nialor) 500 mg one hour prior to Oral Fat Challenge and again 1, 3 and 5 hours after the oral fat load for a total dose of 2 grams.Subjects will undergo plasma and urine collections for 12 hours to assess markers of fat metabolism and inflammation.

Placebo one hour before and 1,3, and 5 hours after oral fat load using heavy cream at 50 grams of fat per square meter of body surface area. Plasma and urine collections for 12 hours

Dyslipidemia

Extended release niacin 2000 mg at hour 0, followed by oral fat challenge at hour 1.

ER Niacin Oral Fat Challenge

Nialor(R) 500mg or Placebo at hour 0, 2, 4, and 6. Oral fat challenge at hour 1 (one hour after first dose of immediate-release niacin)

IR Niacin Oral Fat Challenge

Placebo at hour 0. Oral fat challenge at hour 1, followed by placebo at hours 2,4,and 6

Placebo Oral Fat Challenge

Hospital of the University of Pennsylvania

Presbyterian Hospital

Effects of Niacin On Fatty Acid Trapping

Effect of Niacin On Fatty Acid Trapping

Plasma Triglycerides (TGs) after oral fat challenge will be measured to assess post-prandial lipidemia after niacin and placebo. Parameters of interest are the area under the curve (AUC), time to peak (t-max), and peak concentration (c-max). The relevant units will be mg.h/dl for plasma triglyceride AUC, minutes for time to peak plasma TG and mg/dl for c-max.

lamyropsis/triglyceride

Effects of Silybin in Hypertensive Patients

Effects of Niacin On Fatty Acid Trapping

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