| Trial ID: | L3336 |
| Source ID: | NCT02267317
|
| Associated Drug: |
Eritoran
|
| Title: |
The Effect of TLR4 Inhibition in Obese and Type 2 Diabetic Subjects
|
| Acronym: |
Eritoran2
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02267317/results
|
| Conditions: |
Insulin Sensitivity
|
| Interventions: |
DRUG: Eritoran|DRUG: D5W
|
| Outcome Measures: |
Primary: Effect of Eritoran on Muscle Insulin Sensitivity, Muscle insulin sensitivity = muscle insulin sensitivity is determined by euglycemic hyperinsulinemic clamp procedure. M value (mg glucose / kg of body weight / minute) calculated from the clamp is measured. Higher M value indicates better insulin sensitivity. There is no established reference range., 72 hours|Effect of Eritoran on Hepatic Insulin Sensitivity, Hepatic insulin sensitivity = is determined by euglycemic hyperinsulinemic clamp procedure. Endogenous glucose production or EGP (mg/kg/min) calculated from the clamp is measured. Lower EGP indicates better hepatic insulin sensitivity. There is no established reference range., 72 hours | Secondary: Effect of Eritoran on TLR4 Expression in Muscle Tissue, TLR4 expression in muscle tissue is determined by RNAseq using arbitrary units. Higher TLR4 expression indicates higher inflammatory response. There is no reference range., 72 hours|Effect of Eritoran on TLR4 Expresison in Adipose Tissue, TLR4 expression in the adipose tissue is determined by RNAseq using arbitrary units. Higher TLR4 expression indicates higher inflammatory response. There is no reference range., 72 hours|Effect of Eritoran on TLR4 Expression in Peripheral Blood Monocytes, TLR4 expression in the peripheral blood monocytes is determined by flow cytometry using arbitrary units. Higher TLR4 expression indicates higher inflammatory response. There is no reference range., 72 hours|Effect of Eritoran on Plasma TNF-alpha (Tumor Necrosis Factor-alpha) Concentration, TNF-alpha levels are determined by ELISA. Higher level indicates higher inflammatory response. There is no established reference range., 72 hours|Effect of Eritoran on Intramyocellular Diacylglycerol and Ceramide Content, Intramyocellular diacylglycerol and ceramide content are determined by mass spectrometry. Higher levels have been associated with diabetes., 72 hours
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center at San Antonio
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
15
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-01
|
| Completion Date: |
2018-09
|
| Results First Posted: |
2020-03-04
|
| Last Update Posted: |
2020-03-04
|
| Locations: |
Audie L. Murphy VA Hospital, STVHCS, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02267317
|
