Autonomic Nervous System Diseases Clinical Trial
Official title:
The Effects of Liraglutide on Sudomotor Function and Inflammation in Type 2 Diabetes
The purpose of this study is to conduct an interventional, one year, randomized, double blind, placebo-controlled trial with Liraglutide in patients with type 2 diabetes (diabetes duration of >6 months and <10 years, HbA1c <10%) to evaluate its effects on the peripheral autonomic nervous system, as well as inflammatory markers, and measures of oxidative and nitrosative stress.
The investigators propose to examine the effects of GLP-1 receptor agonist Liraglutide on
autonomic sudomotor function and endothelial and neurovascular functions as well as markers
of inflammation in patients with type 2 diabetes mellitus (T2DM). The primary objective will
be changes in peripheral autonomic function using sudorimetry (Sudoscan) after 1 year of
treatment.
The secondary objectives include changes on markers of inflammation and oxidative/nitrosative
stress including C-reactive protein (CRP), interleukin 1 beta (IL-1β), Interleukin 6 (IL6),
interleukin 12 (IL12), interleukin 10 (IL10), tumor necrosis factor α (TNF α), plasminogen
activator Inhibitor 1 (PAI-1), superoxide dismutase (SOD), nitrotyrosine,
carboxymethyl-lysine (CML), thiobarbituric acid reactive substances (TBARS), and asymmetric
dimethylarginine (ADMA). Additional objectives include changes in neurovascular and
endothelial function, measured by continuous Laser Doppler assessment of skin blood flow in
response to different stimuli; and changes in sensory-motor peripheral nerve function,
measured by clinical neuropathy scores (NSS & NIS), quantitative sensory testing and nerve
conduction testing.
The aim of this study is to capture patients early in the disease process, when autonomic
dysfunction is still potentially reversible. Several studies have shown the presence of
autonomic imbalance in the early stages of diabetes and even in the pre-diabetic state
(impaired glucose tolerance, impaired fasting glucose, and metabolic syndrome). We
hypothesize that by treating type 2 diabetic patients with Liraglutide early in the disease
process (<10 years of diagnosis), we will be able to improve peripheral autonomic imbalance,
endothelial and neurovascular function, and reduce inflammation and oxidative/nitrosative
stress. This will shed further insight into the mechanisms by which glucagon-like peptide-1
(GLP-1) exerts a neuroprotective role and improves the inflammatory process. The possibility
of improving autonomic imbalance, endothelial function and inflammation may have important
impact in the development of new potential therapeutic strategies to abrogate the
microvascular complications of diabetes
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