The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic Axis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01282164
• Date of registration: 19/01/2011
• Prospective Registration: No
• Primary sponsor: The Cleveland Clinic
• Public title: The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic Axis GST
• Scientific title: The Diagnostic Accuracy of the Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and the Hypothalamic-Pituitary-Adrenal Axis
• Date of first enrolment: January 2011
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01282164
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Amir Hamrahian, MD
• Affiliation: The Cleveland Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 to 80 years of age

- male and female

- hypothalamic pituitary disorders (study subjects)

- history of regular, age appropriate menses (control subjects)

- male subjects with normal serum testosterone and follicle stimulating hormone (FSH)
(control subjects)

- normal FSH in post-menopausal subjects (control subjects)

- normal thyroid stimulating hormone (TSH), free thyroxine (T4), prolactin (control
subjects)

Exclusion Criteria:

- unable to give consent

- pregnancy

- active acromegaly

- pheochromocytoma

- active Cushing's disease

- pituitary insult within past 6 weeks

- elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST)

- renal failure

- history of malignancy

- severe acute illness

- uncontrolled hypertension

- Diabetes mellitus (DM) type 1

- Hemoglobin (Hgb) A1c >9% in last 3 months in Type 2 DM

- severe coronary artery disease

- women <50 years of age with untreated hypogonadism

- men with untreated hypogonadism

- growth hormone treatment in the past 3 months



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Adult Growth Hormone Deficiency

Hypothalamic-pituitary Disorders

Intervention(s)

Procedure: Glucagon stimulation test and insulin tolerance test

Primary Outcome(s)

Peak Cortisol Level During Adrenocorticotropin Hormone (ACTH) Stimulation Test [Time Frame: one year]

Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD). [Time Frame: one year]

Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD). [Time Frame: one year]

Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD). [Time Frame: one year]

Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD). [Time Frame: one year]

Peak Growth Hormone (GH) Level in Healthy Volunteers [Time Frame: one year]

Peak Cortisol Level in Healthy Volunteers. [Time Frame: one year]

Secondary ID(s)

10-810

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oregon Health and Science University

Allegheny Endocrinology Associates

Massachusetts General Hospital

Results

• Results available: Yes
• Date Posted: 05/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01282164