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
| Type | Name | Description |
|---|---|---|
| DRUG | insulin infusion | insulin 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 |
| DRUG | Dextrose infusion | Dextrose 12.5% will be infused at a rate to maintain blood glucose level 80-120mg/dl |
| DRUG | Saline Infusion | Saline 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.