N/A N=43 Randomized Diagnostic

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

Adult Growth Hormone Deficiency · Hypothalamic-pituitary Disorders

Bottom Line

View on ClinicalTrials.gov: NCT01282164 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD). — 0.9; 0.6; 0.7 ng/mL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Glucagon stimulation test and insulin tolerance test (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).	0.9; 0.6; 0.7	—
PRIMARY Peak Growth Hormone (GH) Level in Healthy Volunteers	14.0; 4.5; 5.8	—
PRIMARY Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).	0.1; 0.1; 0.1	—
PRIMARY Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).	22.2; 19.5; 22.7	—
PRIMARY Peak Cortisol Level in Healthy Volunteers.	22.1; 18.0; 22.7	—
PRIMARY Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).	6.3; 2.3; 2.5	—
PRIMARY Peak Cortisol Level During Adrenocorticotropin Hormone (ACTH) Stimulation Test	10	—

Summary

The purpose of this study is to find out if the Glucagon Stimulation Test (GST) is a reliable alternative to the Insulin Tolerance Test (ITT) for diagnosis of Growth Hormone Deficiency (GHD) and adrenal insufficiency. In some patients the accuracy of the GST for evaluation of adrenal insufficiency is compared to the adrenocorticotropin hormone (ACTH ) stimulation test.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01282164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.