The Diagnostic Accuracy of the Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and the Hypothalamic-Pituitary-Adrenal Axis (GST)

This study is currently recruiting participants.
Verified August 2013 by The Cleveland Clinic
Sponsor:
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: August 13, 2013
Last verified: August 2013
  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:


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: December 2014
Estimated Primary Completion Date: December 2014 (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: Josephine Chan, PhD 216-445-7488 chanj2@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: Josephine Chan, PhD    216-445-7488    chanj2@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: August 13, 2013
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:
Pituitary Diseases
Dwarfism, Pituitary
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 April 17, 2014