drugset / Trial / NCT02344186

Effects of Liraglutide on ER Stress in Obese Patients With Type 2 Diabetes

NCT02344186

Phase 4 Unknown 12 enrolled Temple University
RandomizedCrossoverSingle-blindOther

Summary

The main objective of the study will be to test the hypothesis that treatment with Liraglutide will decrease ER stress and adipose tissue in obese patients with type 2 diabetes. Experimental Approach: The investigators will use a prospective, single blind, placebo controlled study design to study 12 obese patients with type 2 diabetes mellitus (T2DM). 6 patients will first receive Liraglutide for 24 weeks followed by placebo for 12 weeks. The other 6 patients will first receive placebo for 12 weeks followed by Liraglutide for 24 weeks. Measurements: The investigators will determine glycemic control (with HbA1c), body composition (bioelectric impedance analysis), insulin sensitivity (with hyperinsulinemic-euglycemic clamps), insulin secretion (with oral glucose tolerance testing), energy balance (calories in vs. calories out), plasma lipid levels and obtain subcutaneous fat biopsies to determine ER stress response markers before and after placebo and before and after Liraglutide treatment.

Timeline

Start
2014-05
Primary completion
2022-12-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Liraglutide Peptide 1.8 mg