TY - JOUR
T1 - A randomized triple-blind controlled clinical trial evaluation of sitagliptin in the treatment of patients with non-alcoholic fatty liver diseases without diabetes
AU - Doustmohammadian, Azam
AU - Nezhadisalami, Ahmad
AU - Safarnezhad Tameshke, Fahimeh
AU - Motamed, Nima
AU - Maadi, Mansooreh
AU - Farahmand, Mohammad
AU - Sohrabi, Masoudreza
AU - Clark, Cain C T
AU - Ajdarkosh, Hossein
AU - Faraji, Amir Hossein
AU - Nikkhah, Mehdi
AU - Sobhrakhshankhah, Elham
AU - Ebrahimi, Ramin
AU - Zamani, Farhad
N1 - Copyright © 2022 Doustmohammadian, Nezhadisalami, Safarnezhad Tameshke, Motamed, Maadi, Farahmand, Sohrabi, Clark, Ajdarkosh, Faraji, Nikkhah, Sobhrakhshankhah, Ebrahimi and Zamani.
PY - 2022
Y1 - 2022
N2 - UNLABELLED: The current study aimed to evaluate the efficacy of sitagliptin vs. placebo in treating non-alcoholic fatty liver disease (NAFLD). In a triple-blind randomized clinical trial, we assigned 120 eligible subjects with NAFLD to receive daily dosing of 50 mg sitagliptin (
n = 60) or the placebo (
n = 60) for 56 weeks and lifestyle modification in both groups. Laboratory and anthropometric outcomes were measured, and liver stiffness was assessed using a fibroscan. The primary outcome measures were changes from baseline in fibrosis scores and liver transferases. Out of 120 patients randomized into sitagliptin and placebo groups, 76 patients completed the trial, of whom 44 were in the sitagliptin and 32 in the placebo groups. Patients receiving sitagliptin showed a significant decrease in the fibrosis scores (
P = 0.001). The reductions in the alanine aminotransferase (AST) (
P = 0.036) and aspartate AST (
P < 0.001) levels were also statistically significant. The effect of sitagliptin in reducing fibrosis scores was significantly greater in normal-weight and overweight individuals than in obese individuals (
p = 0.036, and
p = 0.018, respectively), whereas the effects of sitagliptin on AST levels were greater among overweight/obese patients (
p = 0.028, and
p = 0.016, respectively). Sitagliptin reduced fibrosis scores and liver enzymes in NAFLD patients after 56 weeks of therapy. The changes in fibrosis scores were more prominent in patients with normal weight and overweight than obese patients, whereas the effects on AST levels were greater among overweight/obese patients. Other randomized trials with larger sample sizes and longer treatment durations may be required before precise results can be reached.
CLINICAL TRIAL REGISTRATION: [https://www.irct.ir/trial/46140], identifier [IRCT20140430017505N2].
AB - UNLABELLED: The current study aimed to evaluate the efficacy of sitagliptin vs. placebo in treating non-alcoholic fatty liver disease (NAFLD). In a triple-blind randomized clinical trial, we assigned 120 eligible subjects with NAFLD to receive daily dosing of 50 mg sitagliptin (
n = 60) or the placebo (
n = 60) for 56 weeks and lifestyle modification in both groups. Laboratory and anthropometric outcomes were measured, and liver stiffness was assessed using a fibroscan. The primary outcome measures were changes from baseline in fibrosis scores and liver transferases. Out of 120 patients randomized into sitagliptin and placebo groups, 76 patients completed the trial, of whom 44 were in the sitagliptin and 32 in the placebo groups. Patients receiving sitagliptin showed a significant decrease in the fibrosis scores (
P = 0.001). The reductions in the alanine aminotransferase (AST) (
P = 0.036) and aspartate AST (
P < 0.001) levels were also statistically significant. The effect of sitagliptin in reducing fibrosis scores was significantly greater in normal-weight and overweight individuals than in obese individuals (
p = 0.036, and
p = 0.018, respectively), whereas the effects of sitagliptin on AST levels were greater among overweight/obese patients (
p = 0.028, and
p = 0.016, respectively). Sitagliptin reduced fibrosis scores and liver enzymes in NAFLD patients after 56 weeks of therapy. The changes in fibrosis scores were more prominent in patients with normal weight and overweight than obese patients, whereas the effects on AST levels were greater among overweight/obese patients. Other randomized trials with larger sample sizes and longer treatment durations may be required before precise results can be reached.
CLINICAL TRIAL REGISTRATION: [https://www.irct.ir/trial/46140], identifier [IRCT20140430017505N2].
U2 - 10.3389/fmed.2022.937554
DO - 10.3389/fmed.2022.937554
M3 - Article
C2 - 35966875
SN - 2296-858X
VL - 9
SP - 937554
JO - Frontiers in Medicine
JF - Frontiers in Medicine
ER -