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Enzyme Inhibitor

GSK2256294 for Prediabetes

Phase 2
Waitlist Available
Led By Nancy J Brown, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7
Awards & highlights

Study Summary

This trial is testing how different genetic factors may affect the activity of an enzyme in the body, called soluble epoxide hydrolase (sEH). They hope to learn how this enzyme affects insulin sensitivity and blood flow in tissues.

Eligible Conditions
  • Prediabetes
  • Diabetes
  • Obesity
  • Endocrine Disorders

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insulin Sensitivity
Secondary outcome measures
Blood Pressure
Forearm Blood Flow (FBF)
Insulin Signaling in Tissue
+1 more
Other outcome measures
Adipose Tissue Total Epoxyeicosatrienoic Acids (EETs)
Plasma IL-6
Plasma Total Epoxyeicosatrienoic Acids (EETs)
+3 more

Side effects data

From 2020 Phase 1 & 2 trial • 20 Patients • NCT03318783
20%
Deep Vein Thrombosis
20%
Delayed Cerebral Ischemia
10%
Central Line Associated Bloodstream Infection
10%
Aspiration Pneumonia
10%
Urinary Tract Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
GSK2256294
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo then GSK2256294Experimental Treatment2 Interventions
Subjects will receive placebo oral capsule daily by mouth for 7 days, then seven week washout and then GSK2256294 daily by mouth for 7 days.
Group II: GSK2256294 then PlaceboExperimental Treatment2 Interventions
Subjects will receive GSK2256294 daily by mouth for 7 days, then seven week washout and then placebo oral capsule daily by mouth for 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK2256294
2014
Completed Phase 2
~150
Placebo oral capsule
2010
Completed Phase 4
~2380

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,355 Previous Clinical Trials
4,314,954 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,211 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,690 Previous Clinical Trials
6,950,970 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Prostaglandins & Other Lipid MediatorsJournal
Epoxyeicosatrienoic Acids and Glucose Homeostasis in Mice and Men
Luther, James M., and Nancy J. Brown. 2016. “Epoxyeicosatrienoic Acids and Glucose Homeostasis in Mice and Men”. Prostaglandins & Other Lipid Mediators. Elsevier BV. doi:10.1016/j.prostaglandins.2016.07.010.
DiabetologiaJournal
Cytochrome P450 Epoxygenase-derived Epoxyeicosatrienoic Acids Contribute to Insulin Sensitivity in Mice and in Humans
Gangadhariah, Mahesha H., Blake W. Dieckmann, Louise Lantier, Li Kang, David H. Wasserman, Manuel Chiusa, Charles F. Caskey, et al.. 2017. “Cytochrome P450 Epoxygenase-derived Epoxyeicosatrienoic Acids Contribute to Insulin Sensitivity in Mice and in Humans”. Diabetologia. Springer Science and Business Media LLC. doi:10.1007/s00125-017-4260-0.
Prostaglandins & Other Lipid MediatorsJournal
Arg287gln Variant of EPHX2 and Epoxyeicosatrienoic Acids Are Associated with Insulin Sensitivity in Humans
Ramirez, Claudia E., Megan M. Shuey, Ginger L. Milne, Kimberly Gilbert, Nian Hui, Chang Yu, James M. Luther, and Nancy J. Brown. 2014. “Arg287gln Variant of EPHX2 and Epoxyeicosatrienoic Acids Are Associated with Insulin Sensitivity in Humans”. Prostaglandins & Other Lipid Mediators. Elsevier BV. doi:10.1016/j.prostaglandins.2014.08.001.
Prostaglandins & Other Lipid MediatorsJournal
Arg287gln Variant of EPHX2 and Epoxyeicosatrienoic Acids Are Associated with Insulin Sensitivity in Humans
Ramirez, Claudia E., Megan M. Shuey, Ginger L. Milne, Kimberly Gilbert, Nian Hui, Chang Yu, James M. Luther, and Nancy J. Brown. 2014. “Arg287gln Variant of EPHX2 and Epoxyeicosatrienoic Acids Are Associated with Insulin Sensitivity in Humans”. Prostaglandins & Other Lipid Mediators. Elsevier BV. doi:10.1016/j.prostaglandins.2014.08.001.
~2 spots leftby Apr 2025
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