Status:
UNKNOWN
Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Aarhus University Hospital
Conditions:
Adults Growth Hormone Deficiency.
Eligibility:
All Genders
21-55 years
Phase:
NA
Brief Summary
Hypothesis: Pegvisomant combined with the glucagon stimulation test (GST) can improve the accuracy of this test when used to diagnose adult GH and cortisol (steroid hormone)insufficiency. Study aims...
Detailed Description
Background: The diagnosis of GH deficiency in adults is established by provocative testing of GH secretion. The insulin tolerance test (ITT) is widely regarded as the gold standard test for diagnosing...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age 21 to 55 years
- Body weight 60 to 120 kg inclusive
- Stable weight and diet for at least 3 months prior to study entry
Exclusion
- Poor IV access
- Known hypersensitivity to glucagon
- Inability or unwillingness to comply with study procedures
- Clinically significant cardiovascular or cerebrovascular disease
- Current active malignancy other than non-melanoma skin cancer
- Active acromegaly or Cushing's disease
- Pheochromocytoma
- Pregnancy
- Renal failure (serum creatinine \> 2 mg/dl)
- Severe acute illness
- Uncontrolled hypertension (BP \> 160/100 mmHg)
- Emotional/social instability likely to prejudice study completion
- Recurrent or severe unexplained hypoglycemia
- Known or suspected drug/alcohol abuse
- Patients with history of coronary artery disease, cerebrovascular disease, congestive heart failure, arrhythmias and seizure disorder that would be excluded from the ITT arm regardless of age
- Participation in another simultaneous medical investigation or trial
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01804413
Start Date
March 1 2011
End Date
December 1 2013
Last Update
October 24 2013
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239