- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02023918
Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes (PEGIR)
Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Insulin Resistance But Without Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
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San Francisco, California, United States, 94110
- San Francisco General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pegvisomant arm
Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
|
Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
28 days
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ethan J Weiss, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WI178028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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