Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes (PEGIR)
Growth hormone is well known to cause changes in glucose regulation. People with Laron syndrome are born without the growth hormone receptor and are protected from diabetes. Mice who are engineered without the growth hormone receptor are similarly protected from diabetes. Conversely, people who have excessive amounts of growth hormone, such as patients with acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been explored as a possibility for the treatment of type 2 diabetes or insulin resistance in people without acromegaly. In this study, the investigators hope to study the metabolic effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum free fatty acids.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Insulin Resistance But Without Diabetes|
- Insulin sensitivity [ Time Frame: 28 days ] [ Designated as safety issue: No ]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
- De novo lipogenesis [ Time Frame: 28 days ] [ Designated as safety issue: No ]Stable isotopes will be measured at fasting and steady state prior to treatment with pegvisomant and then at day 28 after treatment with pegvisomant.
- Lipolysis [ Time Frame: 28 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02023918
|Contact: Ada P Lee, MDfirstname.lastname@example.org|
|Contact: Ethan Weiss, MD|
|United States, California|
|San Francisco General Hospital||Recruiting|
|San Francisco, California, United States, 94110|
|Contact: Ada Lee, MD 415-476-3090 email@example.com|
|Contact: Ethan Weiss, MD 4155140819 firstname.lastname@example.org|
|Principal Investigator: Ethan J Weiss, MD|
|Sub-Investigator: Morrie Schambelan, MD|
|Sub-Investigator: Kathleen Mulligan, PhD|
|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|