Angela D'ANgelo

Aim: To evaluate the safety of four different dosages of alpha lipoic acid (400, 600, 800, and 1200 mg) as food supplement on adverse events related to alpha lipoic acid consumption and efficacy on glycemic status and lipid profile in subjects with euglycemia or dysglycemia. Methods: We conducted a retrospective, observational study enrolling 322 patients, 83 taking 400 mg/day, 78 taking 600 mg/day, 80 taking 800 mg/day, and 81 taking 1200 mg/day alpha lipoic acid, respectively. Results: In the groups treated with alpha lipoic acid 800 and 1200 mg/day, we registered a reduction of FPG, TC, LDL-C, and Tg compared to baseline (p < 0.05 for all with alpha lipoic acid 800 mg/day, and p < 0.01 for all with alpha lipoic acid 1200 mg/day). The values recorded in the group treated with alpha lipoic acid 1200 mg/day were significantly lower compared to the ones obtained with alpha lipoic acid 400 mg/day. Moreover, alpha lipoic acid 1200 mg/day reduced Hs-CRP levels compared to baseline and compared to 400 mg/day (p < 0.05 for both). In the group treated with alpha lipoic acid at 800 mg/day, 5 subjects with IFG and 1 subject with IGT returned euglycemic. In the group treated with alpha lipoic acid at 1200 mg/day, 11 subjects with IFG and 3 subjects with IGT returned euglycemic. Adverse events of patients during alpha lipoic acid treatment included nausea, vomiting, dizziness, cutaneous rash, hypoglycemia, and hypotension. Adverse events did not differ among the four groups. Conclusion: The chronic use (4 years) of a food supplement containing alpha lipoic acid is well tolerated, without significant differences between lower and higher dosages and improves glycemic status and lipid profile but only if administered at high dosage.

Aim: To evaluate if a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate (Reglicem^®), can ameliorate glycemic status in patients with dysglycemia. Methods: We enrolled 148 patients with impaired fasting plasma glucose or impaired glucose tolerance, not taking any hypoglycemic compounds. Patients were randomized to take nutraceutical or placebo for 3 months, in a randomized, double-blind, placebo-controlled design. Both nutraceutical and placebo were self-administered once a day, 1 tablet during the breakfast. Results: A reduction of fasting and post-prandial plasma glucose was observed with the nutraceutical combination (p < 0.05 vs baseline and p < 0.05 vs placebo, respectively). Furthermore, a decrease of glycated hemoglobin, and fasting plasma insulin was observed with the nutraceutical combination (p < 0.05 vs baseline and p < 0.05 vs placebo, respectively). Then, there was a reduction of homeostasis model assessment index with the nutraceutical combination (p < 0.05 vs baseline and p < 0.05 vs placebo). M value was higher (p < 0.05 vs baseline and p < 0.05 vs placebo) in the nutraceutical combination group at the end of the treatment. We observed a reduction of total cholesterol (TC) (p < 0.05 vs baseline) and triglycerides (Tg) (p < 0.05 vs baseline and p < 0.05 vs placebo) with the nutraceutical combination, respectively. Finally, high sensitivity C-reactive protein was reduced after 3 months with nutraceutical combination therapy (p < 0.05 vs baseline and p < 0.05 vs placebo, respectively). Conclusion: A nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate can be helpful in improving glyco-metabolic compensation, TC and Tg value, and in reducing inflammatory status in patients with dysglycemia.

Introduction: Statin-associated myalgia occurs in about 1–3% of patients in the medical literature. Plasma CoQ10 levels are reduced in patients undergoing statin. Objective: The primary outcome was the detection of clinical symptoms and the perception of pain evaluated throughout specific questionnaires. The secondary outcome was the variation in lipid profile and the variation in safety parameters. Methods: We enrolled 60 Caucasian patients, intolerant to statins. During the run-in period, patients underwent a 1-month wash-out period during which statins were stopped. At the end of the wash-out period, if CPK and/or transaminases returned within an acceptable range, statins were re-introduced at half of the previously taken dose. After one month, patients were randomized to take either a liquid CoQ10 supplement or a placebo for three months at 100 mg/day. Results: The Clinical Index Score for myalgia assessment was lower after 3 months with CoQ10, while it did not change with the placebo. The VAS score was lower after 3 months of CoQ10 supplementation, while no variation was recorded with the placebo. In the group treated with the dietary supplement, CoQ10 plasma concentrations were inversely correlated with CPK levels, Clinical Index Score absolute values, and VAS. Conclusion: The addition of CoQ10 with half dosage statin in patients with previous intolerance to statins improves the perception of clinical symptoms such as asthenia, myalgia or pain.

Aim: To evaluate the actions of a combination of polifenolic composition (extracted from Ascophyllum Nodosum and Fucus Vesiculosus, InSea2^®) and chromium picolinate compared to placebo in addition to previously taken anti-diabetic therapy in patients with type 2 diabetes. Methods: 175 Caucasian patients with type 2 diabetes were randomized to take nutraceutical combination or placebo for 6 months. One hundred and sixty-four cases completed the study. At baseline and after 6 months, glyco-metabolic control and lipid profile were evaluated. Results: Glycated hemoglobin was significantly reduced by the nutraceutical combination, but not by placebo, both compared to baseline (ppppppConclusion: In conclusion, a nutraceutical combination of polifenolic composition and chromium picolinate in addition to previously taken anti-diabetic therapy can be helpful in reducing glycated hemoglobin in patients with type 2 diabetes mellitus.

Introduction The aim of this study was to evaluate the efficacy of two nutraceutical agents aimed to improve lipid profile in a sample of mice. Material and methods Fifty mice were randomly divided into four groups. Control mice were fed a standard diet (SD), while the other three groups...

Introduction: The aim of this study was to compare the effect of ramipril/canrenone versus ramipril/hydrochlorothiazide (HCTZ) combination on atrial fibrillation (AF) recurrence in type 2 diabetic hypertensives with and without cardiac autonomic neuropathy (CAN). Material and methods : A...

The aim of this study was to evaluate the effects of lercanidipine or barnidipine on echocardiographic parameters, in hypertensive, type 2 diabetics with left ventricular hypertrophy. One hundred and forty-four patients were randomized to lercanidipine, 20 mg/day, or barnidipine, 20 mg/day, in addition to losartan, 100 mg/day, for 6 months. We evaluated: blood pressure, fasting plasma glucose (FPG), glycated hemoglobin (HbA_1c), lipid profile, creatinine, estimated glomerular filtration rate (eGFR), sodium, potassium, and acid uric. Echocardiography was performed at baseline and after 6 months. Both lercanidipine and barnidipine decreased blood pressure. Left ventricular mass index was reduced to a greater extent with barnidipine + losartan. Interventricular septal thickness in diastole was reduced by barnidipine + losartan. Posterior wall thickness in diastole was decreased by both treatments, even if barnidipine + losartan were more effective. Ratio of peak early diastolic filling velocity to peak filling velocity at atrial contraction was increased by barnidipine + losartan, but not by lercanidipine + losartan. Finally, isovolumetric relaxation and time and left atrial volume index were reduced by barnidipine + losartan, while lercanidipine + losartan did not affect them. In conclusion, barnidipine + losartan provided a greater improvement of echocardiographic parameters compared to lercanidipine + losartan.