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The Role of TLR4 on Lipid-induced Insulin Resistance (Eritoran1)

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Completed
Phase 2

Conditions

Insulin Sensitivity

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02321111
HSC20140497H

Details and patient eligibility

About

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.

Full description

E5564 = Eritoran

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

10 participants in 3 patient groups

D5W (5% Dextrose in water) + Saline
Active Comparator group
Description:
IV administration of 5% Dextrose in water/D5W (vehicle) 12 mg every 12 hours plus Saline infusion at a rate of 30 mL/hour
Treatment:
Drug: D5W (5% Dextrose in water)
D5W (5% Dextrose in water) + Intralipid
Active Comparator group
Description:
IV Administration of 5% Dextrose in water /D5W (vehicle) 12 mg plus Intralipid infusion at a rate of 30 ml/hour
Treatment:
Drug: D5W (5% Dextrose in water)
Eritoran + Intralipid
Active Comparator group
Description:
IV administration of Eritoran 12 mg every 12 hours plus Intralipid infusion at a rate of 30 ml/hour
Treatment:
Drug: Eritoran

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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