Skip to content

Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Short name PEGIR

NCTNCT02023918 (opens ClinicalTrials.gov in a new tab)Other idWI178028
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
6 participants (actual)
Sponsor
University of California, San Francisco · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jan 2014
Primary completion
Aug 2015
Completion
Dec 2015
First posted
30 Dec 2013 (estimated)
Last update posted
24 Apr 2017
Conditions
Diabetes · Metabolic Syndrome · Insulin Resistance

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 2

    PEGIR

    NCT02023918

    Jan 2014 to Dec 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • pegvisomantDrug

Arms1

  • Experimental

    Pegvisomant arm

    Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Insulin Sensitivity

    Time frame · 28 days

    Registry description

    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 outcomes(1)

  1. Lipolysis

    Time frame · 28 days

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 28 days

Insulin Sensitivity

GroupValue (units on a scale)Spread
Pegvisomant Arm3.061.46
Secondary and other outcome results(1)
Secondary outcomeMean· 28 days

Lipolysis

GroupValue (mg/kg/min)Spread
Pegvisomant Arm0.200.07

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Pegvisomant Armpegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.–0 / 60 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.