Endocrine Abstracts

Background: Dulaglutide has been approved as a hypoglycemic agent for the treatment of patients with T2DM. A positive effect on carbohydrate metabolism and body weight was shown in RCT.

It was found that GLP-1 agonists may prevent the progression of NAFLD directly affecting lipid metabolism and inflammation.

Aim: To assess the effect of dulaglutide on carbohydrate and hepatic metabolism in patients with T2DM and NAFLD in real clinical practice in Moscow Region.

Design: Open observational prospective cohort study of real clinical practice. After approval by LEC 45 pts with T2DM and NAFLD, BMI ≥ 27 kg/m², receiving basic therapy at the time of inclusion with daily dose of metformin ≥ 1,500 mg as monotherapy or as part of a combination therapy were condacted to the study with treatment of dulaglutide subcutaneus injections 1,5 mg weekly for 26 weeks. Mean age 55.6 ± 10.6 лет, 16(36%) men. All patients undergo physical examination withheight, weekly weight, waist and hip circumference measurement, monthly blood sampling tests (HbA1c, FPG, ALT, AST, GGT, lipids, hematology), ultrasound, elastometry using Fibroscan before and after 26 weeks of treatment. Also FIB4, FLI were calculated before and after 26 weeks of treatment. Statistical analysis was done using by MedCalc Version 19.1 using Wilcoxon test for nonparametric and Fisher test for parametric data. Results presented in median with interquartile range (IQR).

Results: In real clinical practice with weekly visits it was found statistically significant difference of weight loss. 5% weight loss was found in 56.0% pts, 10% weight loss – in 7.0% of patient, median weight loss was –5 kg in 26 weeks.

A statistically significant decrease in weight, BMI, waist circumference, HbA1c, ALT levels was detected in the whole group, despite the fact that the goal of more than 5% of the initial weight loss have reached only 56,0% of patients. There was no statistical difference in hip circumference, FPG, AST, GGT, lipids levels. Median of HbA1c decreased from 7.4% (6.1–8.4) to 6,3 (5.6–6.8), ALT median decreased from 67.2 (IQR 35.5–96.9) to 38.2 (IQR 22.6–62.9). A downward trend in FLI and TE was also noted, although absolute values ​​corresponded to a high risk of steatosis.

Conclusion: In real clinical practice Dulaglutide may have a positive effect on weight loss, metabolic and hepatic parameters in patients with NAFLD and T2DM.