| Trial ID: | L5209 |
| Source ID: | NCT04062890
|
| Associated Drug: |
Vigabatrin Pill
|
| Title: |
Inhibiting GABA Transaminase to Relieve Obesity Induced Hyperinsulinemia and Insulin Resistance
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hyperinsulinism|Insulin Resistance|Insulin Sensitivity|Glucose Intolerance|Hypertension
|
| Interventions: |
DRUG: Vigabatrin Pill|DRUG: Placebo oral tablet
|
| Outcome Measures: |
Primary: Fasted serum glucose and insulin, Overnight fasted serum glucose and insulin, 3 weeks after treatment initiation|Glucose Clearance, Clearance of glucose during an oral glucose tolerance test, 3 weeks after treatment initiation|Insulin Sensitivity, Insulin sensitivity measured by glucose infusion rate required to maintain euglycemia during a hyperinsulinemic clamp, 24 days after treatment initiation|Blood Pressure, Measure basal blood pressure both before and 21 days after treatment initiation, 21 days after treatment initiation |
|
| Sponsor/Collaborators: |
Sponsor: University of Arizona | Collaborators: Arizona Department of Health Services
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-12-15
|
| Completion Date: |
2022-12-30
|
| Results First Posted: |
|
| Last Update Posted: |
2019-08-20
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT04062890
|
