Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

San Antonio, Texas 78229


Purpose:

The purpose of this study is to determine whether pharmacologic inhibition of Toll-like receptor 4 (TLR4) with eritoran for injection (E5564) prevents lipid-induced insulin resistance in lean, normal glucose tolerant (NGT) subjects.


Study summary:

E5564 = Eritoran


Criteria:

Inclusion Criteria: - Subjects capable of giving informed consent. - lean (BMI <26 kg/m2) - normal glucose-tolerant subjects (completers) without a family history of Type 2 diabetes mellitus (DM) - Both genders. (50% males) - Age = 18-65 years. Older subjects are excluded because aging is a pro-inflammatory state. - All ethnic groups - Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for >=6 months. - Lab: Hematocrit >=34%, serum creatinine <=1.4 mg/dL, normal electrolytes, urinalysis, and coagulation tests. Liver function tests up to 2x normal range. - Stable body weight (+/-1%) for >=3 months. - One or less sessions of strenuous exercise/wk for last 6 months. Exclusion Criteria: - Presence of diabetes or impaired glucose tolerance based on ADA criteria; - Current treatment with drugs known to affect glucose and lipid homeostasis. Subjects on a stable dose of statin (>3months) are eligible. - Non-steroidal anti-inflammatory drugs or systemic steroid use for more than 1 week within 3 months. - Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies. - History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers. - Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg). - Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.


NCT ID:

NCT02321111


Primary Contact:

Principal Investigator
Nicolas Musi, MD
The University of Texas Health Science Center at San Antonio


Backup Contact:

N/A


Location Contact:

San Antonio, Texas 78229
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.