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.
RCT Entities:
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.
Authors: Anne M Fitzpatrick; Abby D Mutic; Ahmad F Mohammad; Susan T Stephenson; Jocelyn R Grunwell Journal: J Allergy Clin Immunol Pract Date: 2021-10-22
Authors: Edward Yu; Miguel Ruiz-Canela; Cristina Razquin; Marta Guasch-Ferré; Estefania Toledo; Dong D Wang; Christopher Papandreou; Courtney Dennis; Clary Clish; Liming Liang; Monica Bullo; Dolores Corella; Montserrat Fitó; Mario Gutiérrez-Bedmar; José Lapetra; Ramón Estruch; Emilio Ros; Montserrat Cofán; Fernando Arós; Dora Romaguera; Lluis Serra-Majem; Jose V Sorlí; Jordi Salas-Salvadó; Frank B Hu; Miguel A Martínez-González Journal: Diabetes Obes Metab Date: 2018-10-02 Impact factor: 6.577
Authors: Mauricio Krause; Josianne Rodrigues-Krause; Ciara O'Hagan; Paul Medlow; Gareth Davison; Davide Susta; Colin Boreham; Philip Newsholme; Mark O'Donnell; Colin Murphy; Giuseppe De Vito Journal: Eur J Appl Physiol Date: 2014-02 Impact factor: 3.078
Authors: N Kazemi Khoo; A Iravani; M Arjmand; F Vahabi; M Lajevardi; S M Akrami; Z Zamani Journal: Lasers Med Sci Date: 2013-01-29 Impact factor: 3.161
Authors: Thiago R Araujo; Israelle N Freitas; Jean F Vettorazzi; Thiago M Batista; Junia C Santos-Silva; Maria L Bonfleur; Sandra L Balbo; Antonio C Boschero; Everardo M Carneiro; Rosane A Ribeiro Journal: Eur J Nutr Date: 2016-06-17 Impact factor: 5.614
Authors: Kelly J Peyton; Xiao-Ming Liu; Ahmad R Shebib; Fruzsina K Johnson; Robert A Johnson; William Durante Journal: Amino Acids Date: 2018-04-27 Impact factor: 3.520