Clinical Trials Directory

Trials / Completed

CompletedNCT01151605

The Suppression of Toll Like Receptors by Insulin

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
University at Buffalo · Academic / Other
Sex
All
Age
20 Years – 65 Years
Healthy volunteers
Accepted

Summary

This study will help us understand the possible beneficial effects of insulin in inflammation. Inflamamtion is considered to be the cause of atherosclerosis and heart disease.

Detailed description

Obesity and type 2 diabetes are major health problems in the United States and the world. Both conditions are characterized by increased inflammation and oxidative stress and are associated with increased risk of cardiovascular disease. Our previous work shows that insulin exerts a prompt and powerful anti-inflammatory effect, on circulating blood cells and in plasma in healthy subjects and in critically ill patients. Toll like receptors (TLRs) recognize bacterial and viral products like endotoxin and viruses and are major determinants of the inflammatory response against foreign pathogens. In view of the recent data showing that TLRs recognize a range of molecules and proteins that are not of pathogenic source like saturated lipids and that TLRs are involved in the pathogenesis of atherosclerosis which leads to cardiovascular disease and insulin resistance which leads to type 2 diabetes (DM) we hypothesized that insulin infusion suppresses TLRs expression. Our preliminary data show that insulin infusion for 4 hours reduces the levels of many TLRs and thus might protect from inflammation induced conditions We therefore propose to investigate, in more detail, the effect of infusing different doses of insulin on TLRs mRNA and protein levels and its activity in obese and DM subjects over a longer infusion period and a larger number of subjects in circulating white blood cells and in fat tissue. Also we will be comparing the baseline levels of TLRs and TLRs related proteins as well as their modulation by insulin between normal, obese and DM subjects.

Conditions

Interventions

TypeNameDescription
DRUGinsulin infusioninsulin to be infused at 3.5 units/hour along with Dextrose 12.5% at a rate to achieve blood glucose levels between 80-120mg/dl
DRUGDextrose infusionDextrose 12.5% will be infused at a rate to maintain blood glucose level 80-120mg/dl
DRUGSaline InfusionSaline will be infused at 100ml/hr

Timeline

Start date
2008-09-01
Primary completion
2013-09-01
Completion
2013-12-01
First posted
2010-06-28
Last updated
2024-01-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01151605. Inclusion in this directory is not an endorsement.