Background
Evaluation of the short-term effects of dietary supplement
Evaluation of the short-term effects of dietary supplement
“Flebotrofine” on markers of endothelial dysfunction in type
“Flebotrofine” on markers of endothelial dysfunction in type
2 diabetes patients: a pilot study
2 diabetes patients: a pilot study
M. T. Samà1, A. Busti1, G. Bauce2, M. Basile2, M. Zavattaro1, C. Mele1, M. Bagnati2, M. C. Ponziani1, G. Aimaretti1,
G. Bellomo2, R. Rolla2, F. Prodam3
1SCDU Endocrinology, Department of Translational Medicine, University of Eastern Piedmont Novara, 2SCDU Laboratory of Chemical and Clinical Research, Department of Health Sciences, University of Eastern Piedmont Novara, 3Division of Pediatrics, Department of Health Sciences, University of Eastern Piedmont Novara
Our preliminary results show that regular use of Flebotrofine is able to modulate the antioxidant and antithrombotic profile of subjects, by reducing markers of endothelial dysfunction. Therefore, we could hypothesize that its use in high risk patient, such as diabetics, could be a useful support to the traditional therapy, in order to prevent microangiopathy, thus improving the cardiovascular profile.
Conclusions
Recent studies demonstrated that early endothelial dysfunction (microangiopathy) in diabetic patients can be one of the main mechanisms contributing to atherosclerosis. Many factors can lead to microangiopathy and the majority are recognized as important cardiovascular risk factors. Nevertheless, lots of studies demonstrated the role of micronutrients and phytochemicals in preserving endothelial function, such as arginine, flavonoids and antioxidants. In particular, Arginine is the precursor of nitric oxide (NO), whose importance in maintaining endothelial function is well known; moreover, many authors hypothesize its role in regulating postprandial glucose, by stimulating insulin and glucagone like peptide-1 (GLP-1) secretion.
The aim of our study was to evaluate the effect of the regular use of ”Flebotrofine” (AMNOL Chimica Biologica), a dietary supplement rich in arginine and flavonoids, on some markers of endothelial dysfunction and on glycaemic control in a population of diabetic patients.
The second endpoint was to assess the method of quantification of Ng,Ng-Dimetyl-L-Arginine (ADMA), a marker of endothelial dysfunction, which compete with Arginine and inhibits endogenous NO production.
Arginine and β-carotene levels significantly increased after 3 months of therapy (p<0.01 and p<0.001, respectively), but they both decreased 1 months after stopping Flebotrofine. Moreover, the ADMA/Arginine ratio almost halved in the second sample. ApoB level and ApoB/ApoA1 ratio significantly decreased after 3 months of therapy (p<0.001 and p<0.01, respectively) and maintained this trend also 1 month after the stop. Platelets count significantly decreased between the first and the second sample (p<0.001). No significant change in HbA1c level was found.
Patients and Methods
Pilot open label study.
64 diabetic patients (42M, 22 F; mean age 63.3 ys) referring to our Centre were recruited and asked to regularly take Flebotrofine 1 dose/day for 90 days. Blood samples were collected at baseline, after 3 months of treatment and 1 month after the washout. Blood cells count, HbA1c, cholesterol, renal and hepatic function were evaluated. Moreover, Arginine, ADMA, ApoA, ApoB and βcarotene levels were also assessed.
Results
1° 2° 3° P HbA1c (%) 7,3 7,3 7,3 ns Arginine (mM) 84,9 96,8 88,9 <0,01 Beta-carotene (nM) 290 465 339 < 0,001 ApoB (mg/dl) 78,2 72,2 73,5 < 0,001 ApoB/ApoA1 0,63 0,60 0,60 < 0,01 ns: not significant Number of patients 64 Male/Female 42/22Mean Age (years) 63,3
Type 1/ Type 2 DM 3/61
Diet 3
Oral hypoglycemic agents 28
Oral hypoglycemic agents + Insulin 21
