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

Obese subjects according to the International Obesity Task Force (IOTF) criteria aged 6 to 16 years. OB subjects will undergo for 12 months an isocaloric Mediterranen balanced diet plus a daily aerobic training for at least 60 minutes.

Normal weight subjects according to the International Obesity Task Force (IOTF) criteria aged 6 to 16 years and age, sex and pubertal status matched with the OB group

Obesity, Childhood

Cardiovascular Diseases

OB subjects will undergo an isocaloric Mediterranen balanced diet plus a daily aerobic training for at least 60 minutes. All the evaluations will be performed at baseline and after 6 and 12 months of this behavioral therapy. To assess food consumption, foods will be divided according to the classic basic food groups by the Italian Institute of Research on Food and Nutrition. Food frequencies questionnaires, validated for a wide range of ages, will be also completed by parents. Physical activity will be recorded by parents daily on a specific questionnaire.

diet plus physical activity

Paediatric Obesity and Cardiovascular Dysfunction

Paediatric Obesity and Cardiovascular Dysfunction: Searching for Early Markers of Damage

We performed transthoracic echocardiogram to all subjects. Measurements of left ventricle (LV), left atrium diameter (LAD), LA and LV volumes, LV systolic and diastolic function, LV mass and relative wall thickness were obtained and compared between OB and matched NW subjects. A vascular assessment was also performed which included carotid artery intima-media thickness (CIMT), abdominal aortic strain and stiffness and brachial artery flow-mediated dilation (FMD). All these measurements were compared between OB and NW subjects. A sample of 15 individuals has been estimated to be sufficient to demonstrate a difference of 10% in LV diameter with a standard deviation (SD) of 0.44 cm with 90% power and a significance level of 95% in the Student t-test between OB and NW according to published data.

In the OB group, after a 12-h overnight fast, blood samples were taken for measurement of glucose and insulin using standardized methods in the Hospital's Laboratory. Obese subjects also underwent an OGTT. Insulin-resistance at fasting was calculated using the formula of homeostasis model assessment (HOMA)-IR. Insulin sensitivity at fasting and during OGTT was calculated as the formula of the Quantitative Insulin-Sensitivity Check Index (QUICKI) and Matsuda index (ISI).

In the OB group, after a 12-h overnight fast, blood samples were taken for measurement of sUA using standardized methods in the Hospital's Laboratory. sUA was measured by Fossati method reaction.

MetS was defined by using the modified National Cholesterol Education Program/Adult Treatment Panel III (NCEP-ATP III) criteria. A cohort of 75 obese subjects has been estimated to be sufficient to demonstrate differences among numbers of MetS criteria (0-5 criteria according to NCEP-ATPII classification).

OB subjects will perform cardiovascular assessment after 6 and 12 months of isocaloric Mediterranean balanced diet plus aerobic training.

In the OB group, after 6 and 12 month of behavioral treatment, blood samples were taken for measurement of glucose and insulin. Obese subjects also underwent an OGTT. Insulin-resistance at fasting was calculated using the formula of homeostasis model assessment (HOMA)-IR. Insulin sensitivity at fasting and during OGTT was calculated as the formula of the Quantitative Insulin-Sensitivity Check Index (QUICKI) and Matsuda index (ISI). IR will be correlated with cardiovascular measurements

In the OB group, after 6 and 12 month of behavioral treatment, blood samples were taken for measurement of sUA. sUA will be correlated with cardiovascular measurements.

In the OB group, after 6 and 12 month of behavioral treatment, the presence of MetS was evaluated. The presence/absence of MetS and the number of MetS criteria were correlated with cardiovascular measurements.

In the OB group at all study time points, blood samples will be stored and will be analyzed for: IL-8, IL-10, IL-6, TNFα, PAI-1, adiponectin, 3-nitrotyrosine, MDA, ROS generation, MPO, GSH, SOD and NO. An ultrastructural and functional analysis of mitochondria will be also performed. All these dosages will be correlated with cardiovascular abnormalities.

Flavia Prodam

Associated professor

Azienda Ospedaliero Universitaria Maggiore della Carita

Only one group, the obese children group (OB) will be followed for one year. At baseline they received a behavioral intervention which comprises a Mediterranean balanced diet plus daily aerobic training.

A sonographer will perform cardiovascular imaging. Images will be reviewed by an expert pediatric cardiologist and an expert vascular surgeon blinded to patients' clinical data.

uricase/köklük

Effects of Silybin in Hypertensive Patients

Paediatric Obesity and Cardiovascular Dysfunction

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