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Effect of a long‐term oral l ‐arginine supplementation on glucose metabolism: a randomized, double‐blind, placebo‐controlled trial
Author(s) -
Monti L. D.,
Setola E.,
Lucotti P. C. G.,
MarroccoTrischitta M. M.,
Comola M.,
Galluccio E.,
Poggi A.,
Mammì S.,
Catapano A. L.,
Comi G.,
Chiesa R.,
Bosi E.,
Piatti P. M.
Publication year - 2012
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2012.01615.x
Subject(s) - placebo , medicine , diabetes mellitus , hazard ratio , cumulative incidence , impaired glucose tolerance , randomized controlled trial , confidence interval , incidence (geometry) , type 2 diabetes , endocrinology , gastroenterology , cohort , physics , alternative medicine , pathology , optics
Aim : This study assessed the efficacy of long‐term l ‐arginine (l ‐arg) therapy in preventing or delaying type 2 diabetes mellitus. Methods : A mono‐centre, randomized, double‐blind, parallel‐group, placebo‐controlled, phase III trial ( l ‐arg trial) was conducted on 144 individuals affected by impaired glucose tolerance (IGT) and metabolic syndrome (MS). l ‐Arg/placebo was administered (6.4 g/day) on a background structured lifestyle intervention for 18 months plus a 12‐month extended follow‐up period after study drug termination. Fasting glucose levels and glucose tolerance after oral glucose tolerance test were evaluated throughout the study. Results : After 18 months, l ‐arg as compared with placebo did not reduce the cumulative incidence of diabetes [21.4 and 20.8%, respectively, hazard ratio (HR), 1.04; 95% confidence interval (CI), 0.58–1.86] while the cumulative probability to become normal glucose tolerant (NGT) increased (42.4 and 22.1%, respectively, HR, 2.60; 95% CI, 1.51–4.46, p < 0.001). The higher cumulative probability to become of NGT was maintained during the extended period in subjects previously treated with l ‐arg (HR, 3.21; 95% CI, 1.87–5.51; p < 0.001). At the end of the extended period, the cumulative incidence of diabetes in subjects previously treated with l ‐arg was reduced as compared with placebo (27.2 and 47.1%, respectively, HR, 0.42; 95% CI, 0.24–0.75, p < 0.05). During both periods, l ‐arg significantly improved insulin sensitivity and β ‐cell function. Conclusion : Among persons with IGT and MS, the supplementation of l ‐arg for 18 months does not significantly reduce the incidence of diabetes but does significantly increase regression to NGT.