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Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

Short name GST

NCTNCT01282164 (opens ClinicalTrials.gov in a new tab)Other id10-810
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
43 participants (actual)
Sponsor
The Cleveland Clinic · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jan 2011
Primary completion
Jul 2014
Completion
Jul 2014
First posted
24 Jan 2011 (estimated)
Last update posted
17 May 2017
Conditions
Adult Growth Hormone Deficiency · Hypothalamic-pituitary Disorders

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. N/A

    GST

    NCT01282164

    Jan 2011 to Jul 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Glucagon stimulation test and insulin tolerance testProcedure
  • glucagon stimulation test and insulin tolerance testProcedure

Arms2

  • 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).

  • 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).

Primary outcomes7

Outcomes the sponsor listed as primary.

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

    Time frame · one year

    Registry description

    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.

  2. Peak Growth Hormone (GH) Level in Healthy Volunteers

    Time frame · one year

    Registry description

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

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

    Time frame · one year

    Registry description

    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.

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

    Time frame · one year

    Registry description

    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.

  5. Peak Cortisol Level in Healthy Volunteers.

    Time frame · one year

    Registry description

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

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

    Time frame · one year

    Registry description

    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.

  7. Peak Cortisol Level During Adrenocorticotropin Hormone (ACTH) Stimulation Test

    Time frame · one year

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· one year

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

GroupValue (ng/mL)
Patients With 1-2 PHD- Insulin Tolerance Test0.9
Patients With 1-2 PHD- Fixed Dose GST0.6
Patients With 1-2 PHD- Weight Based GST0.7
Primary outcomeMedian· one year

Peak Growth Hormone (GH) Level in Healthy Volunteers

GroupValue (ng/mL)
Control Group- ITT14.0
Control Group- Fixed-dose GST4.5
Control Group- Weight-based GST5.8
Primary outcomeMedian· one year

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

GroupValue (ng/mL)
Patients With 3 or More PHD- Insulin Tolerance Test0.1
Patients With 3 or More PHD- Fixed Dose GST0.1
Patients With 3 or More PHD- Weight Based GST0.1
Primary outcomeMedian· one year

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

GroupValue (ug/dL)
Patients With 1-2 PHD- Insulin Tolerance Test22.2
Patients With 1-2 PHD- Fixed Dose GST19.5
Patients With 1-2 PHD- Weight Based GST22.7
Primary outcomeMedian· one year

Peak Cortisol Level in Healthy Volunteers.

GroupValue (ug/dL)
Control Group- ITT22.1
Control Group- Fixed-dose GST18.0
Control Group- Weight-based GST22.7
Primary outcomeMedian· one year

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

GroupValue (ug/dL)
Patients With 3 or More PHD- Insulin Tolerance Test6.3
Patients With 3 or More PHD- Fixed Dose GST2.3
Patients With 3 or More PHD- Weight Based GST2.5
Primary outcomeMedian· one year

Peak Cortisol Level During Adrenocorticotropin Hormone (ACTH) Stimulation Test

GroupValue (ug/dL)
Patients Older Than 6510

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Study Patientspatients with hypothalamic-pituitary disorders 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–0 / 2816 / 28
ControlThe 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. 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–0 / 149 / 14

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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