Status:
TERMINATED
The Effect of TLR4 Inhibition in Obese and Type 2 Diabetic Subjects
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Insulin Sensitivity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
Detailed Description
E5564 = Eritoran
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02267317
Start Date
January 1 2015
End Date
September 1 2018
Last Update
March 4 2020
Active Locations (1)
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1
Audie L. Murphy VA Hospital, STVHCS
San Antonio, Texas, United States, 78229