Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes (PEGIR)
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|ClinicalTrials.gov Identifier: NCT02023918|
Recruitment Status : Completed
First Posted : December 30, 2013
Results First Posted : March 13, 2017
Last Update Posted : April 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Metabolic Syndrome Insulin Resistance||Drug: pegvisomant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Insulin Resistance But Without Diabetes|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Pegvisomant arm
Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
Other Name: Somavert
- Insulin Sensitivity [ Time Frame: 28 days ]
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
- Lipolysis [ Time Frame: 28 days ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023918
|United States, California|
|San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Ethan J Weiss, MD||University of California, San Francisco|
|Principal Investigator:||Morris Schambelan, MD||University of California, San Francisco|
|Principal Investigator:||Kathleen Mulligan, PhD||University of California, San Francisco|