The Diagnostic Accuracy of the Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and the Hypothalamic-Pituitary-Adrenal Axis (GST)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by The Cleveland Clinic.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
The Cleveland Clinic
Collaborators:
Massachusetts General Hospital
Allegheny Endocrinology Associates
Oregon Health and Science University
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01282164
First received: January 19, 2011
Last updated: February 13, 2012
Last verified: January 2011
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Purpose
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 ACTH stimulation test.
| Condition | Intervention |
|---|---|
|
Adult Growth Hormone Deficiency Hypothalamic-pituitary Disorders |
Procedure: Glucagon stimulation test and insulin tolerance test Procedure: glucagon stimulation test and insulin tolerance test |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | The Diagnostic Accuracy of the Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and the Hypothalamic-Pituitary-Adrenal Axis |
Resource links provided by NLM:
Genetics Home Reference related topics:
combined pituitary hormone deficiency
isolated growth hormone deficiency
metatropic dysplasia
pseudoachondroplasia
U.S. FDA Resources
Further study details as provided by The Cleveland Clinic:
Primary Outcome Measures:
- GST can accurately and safely diagnose adult GHD and evaluate the integrity of the HPA axis in adult patients with hypothalamic-pituitary disorders. [ Time Frame: one year ] [ Designated as safety issue: Yes ]To asses the GH and cortisol levels during GST in patients with adult onset hypothalamic-pituitary disease in control subjedcts matched for age, gender, BMI and estrogen status
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Study patients
patients with growth hormone deficiency or hypothalamic-pituitary disorders
|
Procedure: Glucagon stimulation test and insulin tolerance test
glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure
|
|
Active Comparator: Control
The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
|
Procedure: glucagon stimulation test and insulin tolerance test
glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 FSH (control subjects)
- normal FSH in post-menopausal subjects (control subjects)
- normal TSH, free 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 ALT or AST
- renal failure
- history of malignancy
- severe acute illness
- uncontrolled hypertension
- Type 1 DM
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282164
Contacts
| Contact: Amir Hamrahian, MD | 216-445-8538 | hamraha@ccf.org |
| Contact: Susan Thomas, RN | 216-444-5930 | thomass4@ccf.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02199 | |
| Contact: Karen Liebert 617-726-3870 PULASKI@HELIX.MGH.HARVARD.EDU | |
| Principal Investigator: Beverly MK Biller, MD | |
| United States, Ohio | |
| Cleveland Clinic Endocrinology, Diabetes and Metabolism | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Robert McCoy, RN 216-444-5049 mccoyr@ccf.org | |
| Contact: Susan Thomas, RN 216-444-5930 thomass4@ccf.org | |
| Principal Investigator: Amir Hamrahian, MD | |
| United States, Oregon | |
| Oregon Health and Sciences University | Not yet recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Stacy Legg 503-494-0175 leggs@ohsu.edu | |
| Principal Investigator: Kevin Yuen, MD | |
| United States, Pennsylvania | |
| Allegheny Endocrinology Associates | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: Kellie Spiller, MS 412-359-5143 kspiller@aghendo.com | |
| Principal Investigator: Murray B Gordon, MD | |
Sponsors and Collaborators
The Cleveland Clinic
Massachusetts General Hospital
Allegheny Endocrinology Associates
Oregon Health and Science University
Investigators
| Principal Investigator: | Amir Hamrahian, MD | The Cleveland Clinic |
More Information
No publications provided
| Responsible Party: | The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT01282164 History of Changes |
| Other Study ID Numbers: | 10-810 |
| Study First Received: | January 19, 2011 |
| Last Updated: | February 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by The Cleveland Clinic:
|
glucagon stimulation test insulin tolerance test growth hormone deficiency hypothalamic-pituitary disorders |
Additional relevant MeSH terms:
|
Dwarfism, Pituitary Pituitary Diseases Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism Hypothalamic Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Glucagon Glucagon-Like Peptide 1 Hormones Insulin Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Gastrointestinal Agents Therapeutic Uses Incretins Hypoglycemic Agents |
ClinicalTrials.gov processed this record on June 17, 2013