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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02023918
First Posted: December 30, 2013
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
San Francisco General Hospital
Information provided by (Responsible Party):
University of California, San Francisco
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

    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



Secondary Outcome Measures:
  • 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.


Enrollment: 6
Study Start Date: January 2014
Study Completion Date: December 2015
Primary Completion Date: August 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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>500
  • A1c>6.5
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023918


Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02023918     History of Changes
Other Study ID Numbers: WI178028
First Submitted: December 24, 2013
First Posted: December 30, 2013
Results First Submitted: November 9, 2016
Results First Posted: March 13, 2017
Last Update Posted: April 24, 2017
Last Verified: April 2017

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

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