Combined effects of synbiotic and sitagliptin versus sitagliptin alone in patients with nonalcoholic fatty liver disease

Abstract

Background/AimsNon-alcoholic fatty liver disease (NAFLD) is one of the most prevalent chronic liver diseases in recent years. The aim of this study was to evaluate the effects of sitagliptin with and without a synbiotic supplement in the treatment of patients with NAFLD.MethodsIn total, 138 NAFLD patients aged 18-60 years were enrolled in the study. Patients were randomized to one of the following treatments for 16 weeks: Group I (n=68), sitagliptin 50 mg daily plus placebo (one capsule per day) or group II (n=70) sitagliptin 50 mg daily plus synbiotic (one capsule per day). Changes in fasting blood glucose (FBS), liver enzymes, lipid profile, and body mass index were compared between the groups.ResultsThe mean change in FBS with sitagliptin-placebo from baseline was -10.47±5.77 mg/dL, and that with sitagliptin-synbiotic was -13.52±4.16 mg/dL. There was a significant difference between the groups (P<0.001). The mean change in cholesterol (Chol) was -8.34±28.83 mg/dL with sitagliptin-placebo and -21.25±15.50 mg/dL with sitagliptinsynbiotic. There was a significant difference between the two groups (P=0.029). The administration of sitagliptin-placebo induced an increase of 6.13±27.04 mg/dL in low density lipoprotein (LDL), whereas sitagliptin-synbiotic induced a decrease of 14.92±15.85 mg/dL in LDL. A significant difference was observed between the two groups (P<0.001). On the other hand, in the sitagliptin-synbiotic group, there was significant improvement in aspartate aminotransferase (AST) level compared to the sitagliptin-placebo group (P=0.018).ConclusionsSitagliptin-synbiotic produced greater improvement in FBS, AST, Chol, and LDL compared to sitagliptin alone in patients with NAFLD.

Gut microbiome–targeted therapies in nonalcoholic fatty liver disease: a systematic review, meta-analysis, and meta-regression

“…One study evaluated a synbiotic as an adjunctive treatment to metformin, where both the intervention and control groups received metformin (36). Another study evaluated a synbiotic as an adjunctive treatment to sitagliptin, where both the intervention and control groups received sitagliptin (40).…”

“…The effect of probiotics/synbiotics on BMI was assessed in 12 studies (778 participants), of which 3 evaluated probiotics (21-23, 27) and 9 evaluated synbiotics (30)(31)(32)(33)(34)(35)(36)(37)40). Pediatric studies were excluded from analyses examining changes in BMI.…”

Incretin‐Based Therapies for the Management of Nonalcoholic Fatty Liver Disease in Patients With Type 2 Diabetes

“…In animal models of NAFLD, both glucagon‐like peptide‐1 receptor agonists (GLP‐1Ras) and dipeptidyl peptidase‐4 inhibitor (DPP‐IVi) improve many pathways linked to steatohepatitis, although their efficacy at the clinical level has been mixed (see Tables and ). In open‐label prospective trials, sitagliptin has been found to improve plasma aminotransferases, IHTG, and liver histology . But negative results have also been reported with sitagliptin in open‐label studies and in all three placebo‐controlled trials .…”

Combination of synbiotic and sitagliptin in nonalcoholic fatty liver disease: Is it better than sitagliptin alone?

“…In the current issue, Sayari et al [ 16 ] conducted a randomized, double-blind, controlled trial to evaluate the effect of a combination of sitagliptin, an anti-diabetic drug by inhibiting DPP-4, with synbiotic compared to sitagliptin alone in NAFLD patients with obesity (body mass index 25 or more) and impaired fasting blood glucose. Sixty-eight patients were assigned to the sitagliptin plus synbiotic group and seventy patients were assigned to the sitagliptin alone group.…”

“…Their study showed that the combination of sitagliptin with synbiotic improved asparate aminotransferase ( P =0.018) and metabolic parameters, including fasting blood glucose ( P <0.001), cholesterol ( P <0.029), and low-density lipoprotein ( P <0.001) levels more than sitagliptin therapy alone. The study of Sayari et al revealed significant effects of synbiotic therapy on NAFLD patients through a randomized placebo-controlled trial [ 16 ]. Although gut microbiota-related mechanisms involved in the development of NAFLD have been elucidated and many experimental studies have been reported, clinical studies are insufficient.…”