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

This study has been completed.
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: February 20, 2017
Last verified: February 2017
  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 adrenocorticotropin hormone (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
Intervention Model: Parallel Assignment
Masking: No masking
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:
  • Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD). [ Time Frame: one year ]
    The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and 1-2 pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.

  • Peak Growth Hormone (GH) Level in Healthy Volunteers [ Time Frame: one year ]
    The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers

  • Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD). [ Time Frame: one year ]
    The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease with three or more pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.

  • Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD). [ Time Frame: one year ]
    The peak cortisol level during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and 1-2 pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.

  • Peak Cortisol Level in Healthy Volunteers. [ Time Frame: one year ]
    The peak cortisol levels during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers.

  • Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD). [ Time Frame: one year ]
    The peak cortisol level during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and three or more pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.

  • Peak Cortisol Level During Adrenocorticotropin Hormone (ACTH) Stimulation Test [ Time Frame: one year ]
    The peak cortisol level during ACTH stimulation test in 3 patients with adult onset hypothalamic-pituitary disease who were older than 65 years of age and could not under go insulin tolerance test (ITT).


Enrollment: 42
Study Start Date: January 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study patients
patients with growth hormone deficiency or hypothalamic-pituitary disorders underwent fixed-dose glucagon stimulation test (GST), weight-based GST and insulin tolerance test (ITT).
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 type 2 diabetes mellitus (T2DM), coronary artery disease (CAD), cerebrovascular disease (CVD), seizure
Active Comparator: Control

The control group will consist of healthy volunteers matched to the study group for age, gender, Body mass index (BMI) and estrogen status. Note: Allegheny site is not enrolling in the control group.

Control subjects underwent fixed-dose glucagon stimulation test (GST), weight-based GST and insulin tolerance test (ITT).

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 type 2 diabetes mellitus (T2DM), coronary artery disease (CAD), CVD (cerebrovascular disease), seizure

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282164

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02199
United States, Ohio
Cleveland Clinic Endocrinology, Diabetes and Metabolism
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, United States, 15212
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

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01282164     History of Changes
Other Study ID Numbers: 10-810
Study First Received: January 19, 2011
Results First Received: December 27, 2016
Last Updated: February 20, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
glucagon stimulation test
insulin tolerance test
growth hormone deficiency
hypothalamic-pituitary disorders

Additional relevant MeSH terms:
Pituitary Diseases
Endocrine System Diseases
Dwarfism, Pituitary
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Insulin, Globin Zinc
Insulin
Hormones
Glucagon
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Incretins

ClinicalTrials.gov processed this record on April 21, 2017