Trial · NCT03486223
Soluble Epoxide Hydrolase Inhibition and Insulin Resistance
NCT03486223, Phase 2, Completed, Vanderbilt University Medical Center; results first posted 2023-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Soluble Epoxide Hydrolase Inhibition and Insulin Resistance. Trials, record NCT03486223. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03486223
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Soluble Epoxide Hydrolase Inhibition and Insulin Resistance
- NCT number
- NCT03486223
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, PreDiabetes, Obesity
- Interventions
- GSK2256294, Placebo oral capsule
- First posted
- 2018-04-03
- Last updated
- 2023-03-23
- Results first posted
- 2023-03-23
- Limitations and caveats
- Enrollment was not sufficient for subgroup analysis for race and gender, due to drug expiration.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insulin Sensitivity | Day 7 | Insulin sensitivity determined by Hyperinsulinemic-Euglycemic Clamp as the glucose infusion rate (GIR) per fat-free-mass (FFM) during high dose insulin infusion |
| Secondary | Forearm Blood Flow (FBF) | Day 7 | Insulin stimulated forearm blood flow determined by strain-gauge plethysmography |
| Secondary | Insulin Signaling in Tissue | Day 7 | Insulin stimulated phosphorylated AKT to total AKT ratio (pAKT/AKT) in adipose and muscle tissue sample. AKT is an insulin sensitive serine/threonine kinase also known as protein kinase B. |
| Secondary | Blood Pressure | Day 7 | determined by non-invasive brachial blood pressure measurement (systolic blood pressure, SBP; diastolic blood pressure, DBP) |
| Secondary | Renal Plasma Flow (RPF) | Day 7 | Renal plasma flow determined by PAH infusion, ml/min/per 1.73 m\^2 body surface area |
| Other | Soluble Epoxide Hydrolase Activity | Day 7 | soluble epoxide hydrolase (sEH) activity measured by 14,15-DHET conversion rate in plasma |
| Other | Plasma Total Epoxyeicosatrienoic Acids (EETs) | Day 7 | total Epoxyeicosatrienoic acids in plasma |
| Other | Plasma IL-6 | Day 7 | Plasma cytokine interleukin-6 (IL-6) |
| Other | Plasma VEGF | Day 7 | Plasma vascular endothelial growth factor (VEGF) |
| Other | Adipose Tissue Total Epoxyeicosatrienoic Acids (EETs) | Day 7 | total Epoxyeicosatrienoic acids in adipose tissue (pmol per mg tissue) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Insulin Sensitivity | Day 7 | mg/kg/FFM/min | MEAN | |
| SECONDARY | Forearm Blood Flow (FBF) | Day 7 | Unable to obtain FBF measurement during 2 Placebo study days | ml/min/100ml | MEAN |
| SECONDARY | Insulin Signaling in Tissue | Day 7 | Unable to obtain adipose sample for pAKT measurement during 2 Placebo study days | pAKT/pAKT ratio | MEAN |
| SECONDARY | Blood Pressure | Day 7 | mmHg | MEAN | |
| OTHER_PRE_SPECIFIED | Soluble Epoxide Hydrolase Activity | Day 7 | pmol 14,15-DHET/ml/hr | MEAN | |
| SECONDARY | Renal Plasma Flow (RPF) | Day 7 | Unable to obtain RBF measurement in 8 participants due to availability of PAH | ml/min/per 1.73 m^2 | MEAN |
| OTHER_PRE_SPECIFIED | Plasma Total Epoxyeicosatrienoic Acids (EETs) | Day 7 | Adequate sample not available in 1 participant during GSK | pmol/mL | MEAN |
| OTHER_PRE_SPECIFIED | Plasma IL-6 | Day 7 | pmol/ml | MEAN | |
| OTHER_PRE_SPECIFIED | Plasma VEGF | Day 7 | pg/ml | MEAN | |
| OTHER_PRE_SPECIFIED | Adipose Tissue Total Epoxyeicosatrienoic Acids (EETs) | Day 7 | Adequate sample not available in 1 participant during GSK | pmol/mg | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Insulin Sensitivity | Placebo | 12.0 | Standard Deviation 4.3 | mg/kg/FFM/min | |
| Insulin Sensitivity | GSK2256294 | 11.6 | Standard Deviation 3.7 | mg/kg/FFM/min | |
| Forearm Blood Flow (FBF) | Placebo | 3.5 | Standard Deviation 1.9 | ml/min/100ml | |
| Forearm Blood Flow (FBF) | GSK2256294 | 3.1 | Standard Deviation 1.2 | ml/min/100ml | |
| Insulin Signaling in Tissue | Placebo | Adipose Tissue | 0.21 | Standard Deviation 0.14 | pAKT/pAKT ratio |
| Insulin Signaling in Tissue | GSK2256294 | Adipose Tissue | 0.19 | Standard Deviation 0.18 | pAKT/pAKT ratio |
| Insulin Signaling in Tissue | Placebo | Muscle Tissue | 0.74 | Standard Deviation 0.55 | pAKT/pAKT ratio |
| Insulin Signaling in Tissue | GSK2256294 | Muscle Tissue | 0.73 | Standard Deviation 0.58 | pAKT/pAKT ratio |
| Blood Pressure | Placebo | SBP | 122.9 | Standard Deviation 11.0 | mmHg |
| Blood Pressure | GSK2256294 | SBP | 124.3 | Standard Deviation 9.6 | mmHg |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Intervention 1 | STARTED | Placebo Then GSK2256294 | 8 | |
| Intervention 1 | STARTED | GSK2256294 Then Placebo | 8 | |
| Intervention 1 | COMPLETED | Placebo Then GSK2256294 | 8 | |
| Intervention 1 | COMPLETED | GSK2256294 Then Placebo | 7 | |
| Intervention 1 | NOT COMPLETED | Placebo Then GSK2256294 | 0 | |
| Intervention 1 | NOT COMPLETED | GSK2256294 Then Placebo | 1 | |
| Washout | STARTED | Placebo Then GSK2256294 | 8 | |
| Washout | STARTED | GSK2256294 Then Placebo | 7 | |
| Washout | COMPLETED | Placebo Then GSK2256294 | 8 | |
| Washout | COMPLETED | GSK2256294 Then Placebo | 7 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events16
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 | Flushing | General disorders | Placebo | 0 | 15 | 0 |
| other | Flushing | General disorders | GSK2256294 | 1 | 15 | 1 |
| other | Headache | Nervous system disorders | Placebo | 1 | 15 | 1 |
| other | Headache | Nervous system disorders | GSK2256294 | 1 | 15 | 1 |
| other | Increased frequency of bowel movements | Gastrointestinal disorders | Placebo | 1 | 15 | 1 |
| other | Increased frequency of bowel movements | Gastrointestinal disorders | GSK2256294 | 1 | 15 | 1 |
| other | nausea | Gastrointestinal disorders | Placebo | 1 | 15 | 1 |
| other | nausea | Gastrointestinal disorders | GSK2256294 | 0 | 15 | 0 |
| other | Paresthesia of lips | Nervous system disorders | Placebo | 1 | 15 | 1 |
| other | Paresthesia of lips | Nervous system disorders | GSK2256294 | 0 | 15 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 15 |
| Total, all-cause mortality | GSK2256294 | 0 | 15 |
| Total, other adverse events | Placebo | 2 | 15 |
| Total, other adverse events | GSK2256294 | 2 | 15 |
| Total, serious adverse events | Placebo | 0 | 15 |
| Total, serious adverse events | GSK2256294 | 0 | 15 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DK117875 | Variation in Soluble Epoxide Hydrolase Activity and Human Insulin Sensitivity | LUTHER, JAMES MATTHEW; BROWN, NANCY J. | VANDERBILT UNIVERSITY MEDICAL CENTER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2018 to 2021 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GSK2256294 vs Placebo: deaths from any cause | Trial comparisons |
| GSK2256294 vs Placebo: serious adverse events | Trial comparisons |
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT03486223
GET https://conductscience.org/api/trials/v1/NCT03486223/results?page=2