N/A
Completed N=43
The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic Axis
Adult Growth Hormone Deficiency · Hypothalamic-pituitary Disorders
Source: ClinicalTrials.gov NCT01282164 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: 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
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.
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 | — |
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
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. Informational only — not medical advice.