The Effect of TLR4 Inhibition in Obese and Type 2 Diabetic Subjects

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Insulin Sensitivity

In brief

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.

Key facts

Study ID

NCT02267317

Run by

The University of Texas Health Science Center at San Antonio

People needed

15

Starts

2015-01-01

Expected to finish

2018-09-01

Last updated by the study team

2020-03-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Audie L. Murphy VA Hospital, STVHCS — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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