Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01804413
• Date of registration: 18/02/2013
• Prospective Registration: No
• Primary sponsor: Oregon Health and Science University
• Public title: Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency
• Scientific title: Effects of Pegvisomant-Priming With the Glucagon Stimulation Test in Assessing GH and Cortisol Reserve in Adults: a Randomized Proof-of-Concept Pilot Study
• Date of first enrolment: March 2011
• Target sample size: 10
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01804413
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Kevin C.J. Yuen, MRCP(UK),MD

• Name: Kevin C.J. Yuen, MRCP(UK),MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 21 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Adults Growth Hormone Deficiency.

Intervention(s)

Drug: Pegvisomant

Drug: Regular insulin

Primary Outcome(s)

Peak growth hormone and cortisol levels induced by the pegvisomant-glucagon test compared to those by the insulin tolerance test in assessing the growth hormone and cortisol reserve in adults suspected of adult growth hormone and cortisol deficiencies. [Time Frame: 9 weeks]

Secondary Outcome(s)

Correlation of peak GH and cortisol levels to BMI and fasting glucose, and effects of pegvisomant on IGF-I bioactivity. [Time Frame: 9 weeks]

Secondary ID(s)

IRB6961

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aarhus University Hospital