drugset / Trial / NCT02783196

Effect of Liraglutide on Clock Genes

NCT02783196

Unknown 14 enrolled Tel Aviv University
RandomizedCrossoverTriple-blindTreatment

Summary

This study is undertaken to search whether glucagon-like peptide-1 (GLP-1) analogue, Liraglutide, by enhancing clock gene and AMPK-SIRT-1 mRNA expression, may reverse the metabolic abnormalities of type 2 diabetes, improving overall glycemic excursion, inflammatory cytokines and β-cell function in type 2 diabetes individuals. The investigators aim is to compare the effect of 40 days treatment with Liraglutide (LIR) vs. 40 days with placebo (PLA) in T2D participants on the following end points: Primary end-points: * Change in the oscillation of CG (i.e. CLOCK, BMAL1, Per1, Per2, Cry1, Cry2, Rev-erb-alpha Ror-alpha), AMPK, SIRT1 and inflammatory cytokines mRNA expression in white blood cells (WBCs). Secondary end-points: * Overall daily glycemic variation assessed with continuous glucose monitoring system (CBMS) * Serum levels of inflammatory cytokines (TNF-α, IL-1β, IL-6) * β-Cell function derived from glucose and insulin response to OGTT

Timeline

Start
2016-07
Primary completion
2016-12
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Liraglutide Peptide 1.8 mg Subcutaneous