The Effect of TLR4 Inhibition in Obese and Type 2 Diabetic Subjects
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 (Other)
Phase: Phase 2
Status: Recruiting
Sponsored by: Nicolas Musi, MD Official(s) and/or principal investigator(s): Nicolas Musi, MD, Principal Investigator, Affiliation: Audie L. Murphy VA Hospital, STVHCS San Antonio, Texas, United States 78229
Overall contact: Nicolas Musi, MD, Phone: 210-617-5300, Email: Musi@uthscsa.edu
Summary
To determine whether pharmacologic inhibition of Toll-like receptor 4 (TLR4) with eritoran
for injection (E5564) will reduce inflammation and improve glucose metabolism in insulin
resistant (obese and T2DM) subjects.
Clinical Details
Official title: Phase 2 Study of The Role of Pharmacologic Inhibition of TLR4 With E5564 on Glucose Metabolism in Insulin Resistant Subjects.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Effect of Eritoran on muscle insulin actionEffect of Eritoran on hepatic insulin sensitivity
Secondary outcome: Effect of Eritoran on inflammatory signaling in muscle and adipose tissueEffect of Eritoran on TLR4 expression in 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) with normal glucose-tolerant subjects without a family history
of type 2 DM
- obese (BMI 30-37 kg/m2) with normal glucose-tolerant subjects
- Type 2 DM subjects base on ADA criteria, who have HbA1c <8. 5% and control with diet
or sulfonylureas.
- 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:
- Current treatment with drugs known to affect glucose and lipid homeostasis. Subjects
on a stable dose of statin (>3 months) 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: 210-617-5300, 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
|