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

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ClinicalTrials.gov Identifier: NCT02023918
Recruitment Status : Completed
First Posted : December 30, 2013
Results First Posted : March 13, 2017
Last Update Posted : April 24, 2017
Sponsor:
Collaborator:
San Francisco General Hospital
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Metabolic Syndrome
Insulin Resistance
Intervention Drug: pegvisomant
Enrollment 6

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pegvisomant Arm
Hide Arm/Group Description

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

pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Pegvisomant Arm
Hide Arm/Group Description pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
56.5  (3.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
0
   0.0%
Male
6
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Insulin Sensitivity
Hide 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

Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients were compared after treatment to their own baseline
Arm/Group Title Pegvisomant Arm
Hide Arm/Group Description:
Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline HOMA-IR 3.06  (1.46)
HOMA-IR after 28 days of treatment 3.33  (2.76)
2.Secondary Outcome
Title Lipolysis
Hide 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.
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Ra glycerol reported
Arm/Group Title Pegvisomant Arm
Hide Arm/Group Description:
Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: mg/kg/min
Ra glycerol fasting state baseline 0.20  (0.07)
Ra glycerol fasting state after 28 days of peg 0.21  (0.02)
Ra glycerol steady state baseline -0.01  (0.2)
Ra glycerol steady state treatment 28 days peg 0.4  (0.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pegvisomant Arm
Hide Arm/Group Description pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
All-Cause Mortality
Pegvisomant Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pegvisomant Arm
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pegvisomant Arm
Affected / at Risk (%)
Total   0/6 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Ethan Weiss
Organization: UCSF
Phone: 4155140819
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