| Trial ID: | L4549 |
| Source ID: | NCT02023918
|
| Associated Drug: |
Pegvisomant
|
| Title: |
Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes
|
| Acronym: |
PEGIR
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02023918/results
|
| Conditions: |
Diabetes|Metabolic Syndrome|Insulin Resistance
|
| Interventions: |
DRUG: pegvisomant
|
| Outcome Measures: |
Primary: Insulin Sensitivity, Investigators will measure insulin sensitivity via hyperinsulinemic euglycemic clamp prior to the initiation of the study medication and then again at the end of the 28 days to evaluate the effect of pegvisomant on insulin sensitivity and reported as HOMA-IR. HOMA-IR was derived from fasting insulin and fasting glucose by the calculation: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5, 28 days | Secondary: Lipolysis, Treatment with pegvisomant is expected to alter lipolysis. To assess this investigators will do fasting and steady state stable isotope measurements prior to treatment with pegvisomant and at day 28 after treatment with pegvisomant., 28 days
|
| Sponsor/Collaborators: |
Sponsor: University of California, San Francisco | Collaborators: San Francisco General Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
6
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-01
|
| Completion Date: |
2015-12
|
| Results First Posted: |
2017-03-13
|
| Last Update Posted: |
2017-04-24
|
| Locations: |
San Francisco General Hospital, San Francisco, California, 94110, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02023918
|
