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 August 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: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Diabetes
Metabolic Syndrome
Insulin Resistance
Drug: pegvisomant
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 6
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegvisomant arm
Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
Drug: pegvisomant
Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
Other Name: Somavert

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02023918

Contacts
Contact: Ada P Lee, MD 415-476-3090 pegirstudy@ucsf.edu
Contact: Ethan Weiss, MD

Locations
United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Ada Lee, MD    415-476-3090    pegirstudy@ucsf.edu   
Contact: Ethan Weiss, MD    4155140819    ethan.weiss@ucsf.edu   
Principal Investigator: Ethan J Weiss, MD         
Sub-Investigator: Morrie Schambelan, MD         
Sub-Investigator: Kathleen Mulligan, PhD         
Sponsors and Collaborators
University of California, San Francisco
San Francisco General Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02023918     History of Changes
Other Study ID Numbers: WI178028
Study First Received: December 24, 2013
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Growth hormone antagonism

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014