ABSTRACT
BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is strongly associated with type 2 diabetes mellitus (T2DM). Lifestyle intervention remains a preferred treatment modality for NAFLD. The glucagon-like peptide (GLP-1) receptor agonists and sodium-glucose cotransporter-2 (SGLT-2) inhibitors have been developed as new glucose-lowering drugs, which can improve fatty liver via an insulin-independent glucose-lowering effect. However, studies exploring the efficacy of GLP-1 receptor agonists combined with SGLT-2 inhibitors in patients with NAFLD and T2DM are scanty. Thus, the present randomised controlled trial aims at comparing the efficacy and safety of semaglutide plus empagliflozin with each treatment alone in patients with NAFLD and T2DM. METHODS: This 52-week double-blinded, randomised, parallel-group, active-controlled trial evaluates the effects of semaglutide, empagliflozin and semaglutide + empagliflozin in 105 eligible overweight/obese subjects with NAFLD and T2DM. The primary outcome will be a change from baseline to week 52 in the controlled attenuation parameter, free fatty acid and glucagon. Secondary endpoints include changes in liver stiffness measurement, liver enzymes, blood glucose, lipid levels, renal function, electrolyte balances, minerals and bone metabolism, cytokines, high-sensitivity C-reactive protein, ferritin, anthropometric indicators, nonalcoholic fatty liver fibrosis score, fibrosis 4 score and homeostatic model assessment for insulin resistance. In addition, intention-to-treat, interim analysis and safety analysis will be performed. DISCUSSION: This double-blinded, randomised, clinical trial involves a multi-disciplinary approach and aims to explore the synergistic effects of the combination of semaglutide and empagliflozin. The results can provide important insights into mechanisms of GLP-1 receptor agonists and/or SGLT-2 inhibitors in patients with NAFLD and T2DM. TRIAL REGISTRATION: This study has been registered with Chinese Clinical Trial Registry (ChiCTR2300070674).
Subject(s)
Benzhydryl Compounds , Diabetes Mellitus, Type 2 , Glucagon-Like Peptides , Glucosides , Non-alcoholic Fatty Liver Disease , Humans , Non-alcoholic Fatty Liver Disease/drug therapy , Non-alcoholic Fatty Liver Disease/complications , Glucosides/therapeutic use , Glucosides/adverse effects , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/complications , Glucagon-Like Peptides/therapeutic use , Benzhydryl Compounds/therapeutic use , Benzhydryl Compounds/adverse effects , Middle Aged , Male , Double-Blind Method , Female , Hypoglycemic Agents/therapeutic use , Hypoglycemic Agents/adverse effects , Adult , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use , Drug Therapy, Combination , Blood Glucose/metabolism , Aged , Treatment OutcomeABSTRACT
In this paper, we demonstrate an adaptive liquid lens with a tunable field of view (FOV). The proposed liquid lens consists of an actuator and a lens chamber, the annular sheet is just placed on the liquid-liquid (L-L) interface in order to change the curvature and steer the tilt angle of the interface. Different from the conventional FOV adjustable lens combined with a liquid lens and a liquid prism, the proposed lens requires only one L-L interface to achieve the focal length change and FOV deflection. Moreover, the proposed lens reduces aberrations while maintaining high resolution. The experiments show that the optical power range is -27 m-1 to 30 m-1. It can realize the FOV deflection while tuning the focal length, with an angular resolution of 37"05. The proposed lens can be applied to telescopic system and microscopic system.
