Context: A reduced activity of the GH/IGF-I axis in chronic heart failure (CHF) has been described by several independent groups and is associated with poor clinical status and outcome. Objective: The aim of the current study was to investigate the prevalence of GH deficiency in a patient population with CHF and evaluate the cardiovascular effects of GH replacement therapy. Design and Setting: The randomized, single-blind, controlled trial was conducted at the Federico II University. Participants: One hundred fifty-eight patients with CHF, New York Heart Association class II-IV, underwent a GH stimulation test. Sixty-three patients satisfied the criteria for GH deficiency, and 56 of them were enrolled in the trial. Intervention: The treated group (n = 28) received GH at a replacement dose of 0.012 mg/kg every second day (∼2.5 IU). Main Outcomes Measures: Changes in physical performance and various cardiovascular indexes were measured. Results: GH replacement therapy improved quality of life score (from 46 ± 5 to 38 ± 4; P < 0.01), increased peak oxygen uptake and exercise duration (from 12.9 ± .9 to 14.5 ± 1 ml/kg · min and from 520 ± 36 to 586 ± 43 sec, respectively; P < 0.01), and flow-mediated vasodilation (from 8.8 ± 1.3 to 12.7 ± 1.2%; P < 0.01). GH increased left ventricular ejection fraction (from 34 ± 2 to 36 ± 2%; P < 0.01) and reduced circulating N-terminal pro-brain natriuretic peptide levels (from 3201 ± 900 to 2177 ± 720 pg/ml; P = 0.006). No significant changes from baseline were observed in controls. Conclusions: As many as 40% of patients with CHF are GH deficient. GH replacement therapy in these patients improves exercise capacity, vascular reactivity, left ventricular function, and indices of quality of life. GH deficiency is a common finding in chronic heart failure, and GH replacement therapy improves quality of life, exercise performance, left ventricular architecture, and function.

To test the efficacy of a proprietary nutraceutical combination in reducing insulin resistance associated with the metabolic syndrome (MetS). Sixty-four patients with MetS followed at a tertiary outpatient clinic were randomly assigned to receive either placebo or a proprietary nutraceutical combination (AP) consisting of berberine, policosanol and red yeast rice, in a prospective, double-blind, placebo-controlled study. Evaluations were performed at baseline and after 18 wk of treatment. The homeostasis model assessment of insulin resistance (HOMA-IR) index was the primary outcome measure. Secondary endpoints included lipid panel, blood glucose and insulin fasting, after a standard mixed meal and after an oral glucose tolerance test (OGTT), flow-mediated dilation (FMD), and waist circumference. Fifty nine patients completed the study, 2 withdrew because of adverse effects. After 18 wk there was a significant reduction in the HOMA-IR index in the AP group compared with placebo (ΔHOMA respectively -0.6 ± 1.2 vs 0.4 ± 1.9; P < 0.05). Total and low density lipoprotein cholesterol also significantly decreased in the treatment arm compared with placebo (Δlow density lipoprotein cholesterol -0.82 ± 0.68 vs -0.13 ± 0.55 mmol/L; P < 0.001), while triglycerides, high density lipoprotein cholesterol, and the OGTT were not affected. In addition, there were significant reductions in blood glucose and insulin after the standard mixed meal, as well as an increase in FMD (ΔFMD 1.9 ± 4.2 vs 0 ± 1.9 %; P < 0.05) and a significant reduction in arterial systolic blood pressure in the AP arm. This short-term study shows that AP has relevant beneficial effects on insulin resistance and many other components of MetS.

Insulin resistance: Is it time for primary prevention?