Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes (PEGIR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of California, San Francisco
Sponsor:
Collaborator:
San Francisco General Hospital
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02023918
First received: December 24, 2013
Last updated: January 28, 2014
Last verified: January 2014

December 24, 2013
January 28, 2014
January 2014
September 2014   (final data collection date for primary outcome measure)
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
Insulin sensitivity [ Time Frame: 28 days ] [ Designated as safety issue: No ]
We 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
Complete list of historical versions of study NCT02023918 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
    We expect treatment with pegvisomant to alter lipolysis. To assess this we will do fasting and steady state stable isotope measurements prior to treatment with pegvisomant and at day 28 after treatment with pegvisomant.
Not Provided
Not Provided
 
Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes
Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Insulin Resistance But Without Diabetes

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Metabolic Syndrome
  • Insulin Resistance
Drug: pegvisomant
Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
Other Name: Somavert
Experimental: Pegvisomant arm
Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
Intervention: Drug: pegvisomant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI between 18-35
  • Homeostatic model assessment - insulin resistance (HOMA-IR) >2.77
  • Able to administer daily subcutaneous injections of pegvisomant

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding in the last 6 months
  • Liver function tests greater than 3x the upper limits of normal
  • unstable diet over the last 3 months
  • unstable weight over the last 6 months
  • unstable lipid lowering regimen
  • diabetes - type 1 or type 2
  • History of major gastrointestinal surgery
  • History of pancreatic, liver, biliary, or intestinal disease
  • Fasting blood glucose >126
  • Fasting triglycerides>300
  • A1c>6.5
Both
18 Years to 80 Years
Yes
Contact: Sarah Nordstrom, PhD 415-476-3090 pegirstudy@gmail.com
Contact: Ada P Lee, MD 415-476-3090 ada.lee@ucsf.edu
United States
 
NCT02023918
WI178028
No
University of California, San Francisco
University of California, San Francisco
San Francisco General Hospital
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
University of California, San Francisco
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP