Trial · NCT02267317
The Effect of TLR4 Inhibition in Obese and Type 2 Diabetic Subjects
NCT02267317, Phase 2, Terminated, The University of Texas Health Science Center at San Antonio; results first posted 2020-03-04
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. The Effect of TLR4 Inhibition in Obese and Type 2 Diabetic Subjects. Trials, record NCT02267317. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02267317
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of TLR4 Inhibition in Obese and Type 2 Diabetic Subjects
- NCT number
- NCT02267317
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Conditions
- Insulin Sensitivity
- Interventions
- Eritoran, D5W
- First posted
- 2014-10-17
- Last updated
- 2020-03-04
- Results first posted
- 2020-03-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effect of Eritoran on Muscle Insulin Sensitivity | 72 hours | 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. |
| Primary | Effect of Eritoran on Hepatic Insulin Sensitivity | 72 hours | 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. |
| Secondary | Effect of Eritoran on TLR4 Expression in Muscle Tissue | 72 hours | TLR4 expression in muscle tissue is determined by RNAseq using arbitrary units. Higher TLR4 expression indicates higher inflammatory response. There is no reference range. |
| Secondary | Effect of Eritoran on TLR4 Expresison in Adipose Tissue | 72 hours | 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. |
| Secondary | Effect of Eritoran on TLR4 Expression in Peripheral Blood Monocytes | 72 hours | 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. |
| Secondary | Effect of Eritoran on Plasma TNF-alpha (Tumor Necrosis Factor-alpha) Concentration | 72 hours | TNF-alpha levels are determined by ELISA. Higher level indicates higher inflammatory response. There is no established reference range. |
| Secondary | Effect of Eritoran on Intramyocellular Diacylglycerol and Ceramide Content | 72 hours | Intramyocellular diacylglycerol and ceramide content are determined by mass spectrometry. Higher levels have been associated with diabetes. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effect of Eritoran on Muscle Insulin Sensitivity | 72 hours | Data from T2DM subjects and Lean subject were not collected for primary outcome measure because of insufficient number of participants in the 2 groups. | mg/kg/min | MEAN |
| PRIMARY | Effect of Eritoran on Hepatic Insulin Sensitivity | 72 hours | Data from T2DM subjects and Lean subject were not collected for primary outcome measure because of insufficient number of participants in the 2 groups. | mg/kg/min | MEAN |
| SECONDARY | Effect of Eritoran on TLR4 Expression in Muscle Tissue | 72 hours | The total number of obese subjects enrolled is 9. However, we were only able to obtain muscle biopsies from 7 subjects. In addition, data from T2DM subjects and Lean subject were not collected for this secondary outcome measure because of insufficient number of participants in the 2 groups. | AU | MEAN |
| SECONDARY | Effect of Eritoran on TLR4 Expresison in Adipose Tissue | 72 hours | The total number of obese subjects enrolled is 9. However, we were only able to obtain fat biopsies from 4 subjects. In addition, data from T2DM subjects and Lean subject were not analyzed for this secondary outcome measure because of insufficient number of participants in the 2 groups. | AU | MEAN |
| SECONDARY | Effect of Eritoran on TLR4 Expression in Peripheral Blood Monocytes | 72 hours | Data from T2DM subjects and Lean subject were not analyzed because the number of participants was insufficient in the 2 groups. | AU | MEAN |
| SECONDARY | Effect of Eritoran on Plasma TNF-alpha (Tumor Necrosis Factor-alpha) Concentration | 72 hours | Data from T2DM subjects and Lean subject were not analyzed because the number of participants was insufficient in the 2 groups. | pg/ml | MEAN |
| SECONDARY | Effect of Eritoran on Intramyocellular Diacylglycerol and Ceramide Content | 72 hours | Data were not collected due to lack of funding. |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effect of Eritoran on Muscle Insulin Sensitivity | Obese Group - Placebo | 8.0 | Standard Error 0.9 | mg/kg/min | |
| Effect of Eritoran on Muscle Insulin Sensitivity | Obese Group - Eritoran | 10.6 | Standard Error 1.1 | mg/kg/min | |
| Effect of Eritoran on Hepatic Insulin Sensitivity | Obese Group - Placebo | 2.0 | Standard Error 0.2 | mg/kg/min | |
| Effect of Eritoran on Hepatic Insulin Sensitivity | Obese Group - Eritoran | 1.9 | Standard Error 0.1 | mg/kg/min | |
| Effect of Eritoran on TLR4 Expression in Muscle Tissue | Obese Group - Placebo | 1 | Standard Error 0.11 | AU | |
| Effect of Eritoran on TLR4 Expression in Muscle Tissue | Obese Group - Eritoran | 1.16 | Standard Error 0.16 | AU | |
| Effect of Eritoran on TLR4 Expresison in Adipose Tissue | Obese Group - Placebo | 1 | Standard Deviation 0.11 | AU | |
| Effect of Eritoran on TLR4 Expresison in Adipose Tissue | Obese Group - Eritoran | 1.22 | Standard Deviation 0.07 | AU | |
| Effect of Eritoran on TLR4 Expression in Peripheral Blood Monocytes | Obese Group - Placebo | 1.1 | Standard Error 0.1 | AU | |
| Effect of Eritoran on TLR4 Expression in Peripheral Blood Monocytes | Obese Group - Eritoran | 1.2 | Standard Error 0.1 | AU |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Infusion1 | STARTED | Obese Group - D5W - Eritoran | 8 | |
| Infusion1 | STARTED | Obese Group - Eritoran - D5W | 3 | |
| Infusion1 | STARTED | Diabetes (T2DM) Group - D5W - Eritoran | 1 | |
| Infusion1 | STARTED | Diabetes (T2DM) Group - Eritoran - D5W | 2 | |
| Infusion1 | STARTED | Lean Group - D5W - Eritoran | 0 | |
| Infusion1 | STARTED | Lean Group - Eritoran - D5W | 1 | |
| Infusion1 | COMPLETED | Obese Group - D5W - Eritoran | 8 | |
| Infusion1 | COMPLETED | Obese Group - Eritoran - D5W | 3 | |
| Infusion1 | COMPLETED | Diabetes (T2DM) Group - D5W - Eritoran | 1 | |
| Infusion1 | COMPLETED | Diabetes (T2DM) Group - Eritoran - D5W | 2 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Phlebitis Grade 1, 2 or 3 | Vascular disorders | Obese Group - Placebo | 7 | 11 | |
| other | Phlebitis Grade 1, 2 or 3 | Vascular disorders | Obese Group - Eritoran | 9 | 11 | |
| other | Phlebitis Grade 1, 2 or 3 | Vascular disorders | Diabetes (T2DM) Group - Placebo | 1 | 3 | |
| other | Phlebitis Grade 1, 2 or 3 | Vascular disorders | Diabetes (T2DM) Group - Eritoran | 2 | 3 | |
| other | Phlebitis Grade 1, 2 or 3 | Vascular disorders | Lean/Healthy Group - Placebo | 0 | 1 | |
| other | Phlebitis Grade 1, 2 or 3 | Vascular disorders | Lean/Healthy Group - Eritoran | 0 | 1 | |
| other | Dermatology | Skin and subcutaneous tissue disorders | Obese Group - Placebo | 1 | 11 | |
| other | Dermatology | Skin and subcutaneous tissue disorders | Obese Group - Eritoran | 0 | 11 | |
| other | Dermatology | Skin and subcutaneous tissue disorders | Diabetes (T2DM) Group - Placebo | 0 | 3 | |
| other | Dermatology | Skin and subcutaneous tissue disorders | Diabetes (T2DM) Group - Eritoran | 0 | 3 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Obese Group - Placebo | 0 | 11 |
| Total, all-cause mortality | Obese Group - Eritoran | 0 | 11 |
| Total, all-cause mortality | Diabetes (T2DM) Group - Placebo | 0 | 3 |
| Total, all-cause mortality | Diabetes (T2DM) Group - Eritoran | 0 | 3 |
| Total, all-cause mortality | Lean/Healthy Group - Placebo | 0 | 1 |
| Total, all-cause mortality | Lean/Healthy Group - Eritoran | 0 | 1 |
| Total, other adverse events | Obese Group - Placebo | 9 | 11 |
| Total, other adverse events | Obese Group - Eritoran | 9 | 11 |
| Total, other adverse events | Diabetes (T2DM) Group - Placebo | 1 | 3 |
| Total, other adverse events | Diabetes (T2DM) Group - Eritoran | 2 | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36066991 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02267317
GET https://conductscience.org/api/trials/v1/NCT02267317/flow?page=2