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

NCT01282164 | Completed Results

• 1 other identifier: 10-810
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Adult Growth Hormone Deficiency; Hypothalamic-pituitary Disorders

Keywords

glucagon stimulation test; insulin tolerance test; growth hormone deficiency; hypothalamic-pituitary disorders

Outcome Measures

Primary Outcomes (7)

• Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).

  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.

  one year

• Peak Growth Hormone (GH) Level in Healthy Volunteers

  The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers

  one year

• Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).

  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.

  one year

• Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).

  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.

  one year

• Peak Cortisol Level in Healthy Volunteers.

  The peak cortisol levels during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers.

  one year

• Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).

  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.

  one year

• Peak Cortisol Level During Adrenocorticotropin Hormone (ACTH) Stimulation Test

  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).

  one year

Study Arms (2)

Study patients

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

glucagon stimulation test and insulin tolerance test PROCEDURE

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

Study patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Massachusetts General Hospital: collaborator
• Allegheny Endocrinology Associates: collaborator
• Oregon Health and Science University: collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02199, United States

Location

Cleveland Clinic Endocrinology, Diabetes and Metabolism

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Limitations and Caveats

This includes the relatively small number of subjects, and that the majority of patients had growth hormone deficiency (GHD), so a larger study assessing adults with mild hypothalamic-pituitary disease and possible but unconfirmed GHD is required.

Results Point of Contact

• Title: Dr. Amir H. Hamrahian
• Organization: Cleveland Clinic

hamraha@ccf.org

216-445-8555

Study Officials

• Amir Hamrahian, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 24, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 17, 2017
• Results First Posted: April 5, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)