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The Role of TLR4 on Lipid-induced Insulin Resistance

Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Insulin Sensitivity

Intervention: Eritoran (Drug); D5W (5% Dextrose in water) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: The University of Texas Health Science Center at San Antonio

Official(s) and/or principal investigator(s):
Nicolas Musi, MD, Principal Investigator, Affiliation: The University of Texas Health Science Center at San Antonio

Overall contact:
Nicolas Musi, MD, Phone: 2106175300, Email: Musi@uthscsa.edu

Summary

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.

Clinical Details

Official title: The Role of TLR4 on Lipid-Induced Insulin Resistance

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Effect of Eritoran on muscle insulin action

Effect of Eritoran on hepatic insulin sensitivity

Secondary outcome:

Effect of Eritoran on Inflammatory signaling in muscle

Effect of Eritoran on TLR4 expression on peripheral blood monocytes

Effect of Eritoran on Plasma cytokine concentration

Effect of Eritoran on Intramyocellular diacylglycerol and ceramide content

Detailed description: E5564 = Eritoran

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Nicolas Musi, MD, Phone: 2106175300, Email: Musi@uthscsa.edu

Audie L. Murphy VA Hospital, STVHCS, San Antonio, Texas 78229, United States; Recruiting
Nicolas Musi, MD, Phone: 210-617-5300, Email: Musi@uthscsa.edu
Lauri Che Kelly, RN, Phone: 2106175300, Ext: 14731, Email: che@uthscsa.edu
Nicolas Musi, MD, Principal Investigator
Additional Information

Starting date: January 2015
Last updated: July 20, 2015

Page last updated: August 20, 2015

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