Adult Growth Hormone DeficiencyGSTNCT01282164
The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic Axis
A study testing Glucagon stimulation test and insulin tolerance test in people with Adult Growth Hormone Deficiency and Hypothalamic-pituitary Disorders, run by The Cleveland Clinic at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Growth Hormone Deficiency, Hypothalamic-pituitary Disorders
- What is being tested?
- Glucagon stimulation test and insulin tolerance test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- unable to give consent
- pregnancy
- active acromegaly
- pheochromocytoma
- active Cushing's disease
- pituitary insult within past 6 weeks
Show all 17Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02199
Cleveland Clinic Endocrinology, Diabetes and Metabolism
Cleveland, Ohio, 44195
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, 15212
Oregon Health and Sciences University
Portland, Oregon, 97239
About this study
Official title: The Diagnostic Accuracy of the Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and the Hypothalamic-Pituitary-Adrenal Axis
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.
Read the detailed description
Growth hormone is a protein that is produced by the pituitary gland and influences the metabolism (how fast things work) of other proteins, carbohydrates, and fats in the body. This allows the growth hormone to help humans keep a healthy balance between fat, muscle and bone throughout their life. Some people have what is called Growth Hormone Deficiency (GHD), which means that they do not produce enough growth hormone. GHD may lead to a tendency to be fat, (especially around the abdominal area), a reduced ability to exercise, heart disease, an increased possibility of breaking bones, and a general reduced quality of life.
GHD is usually evaluated through growth hormone stimulation test(s). One of the most reliable tests to evaluate if someone has GHD is by using arginine + Growth Hormone Releasing Hormone (GHRH) test. However, Since 2008 GHRH is no longer available in the USA. For this reason there has been a significant gap for an alternative test for evaluation of patients suspected to have GHD that can be easily performed and be reliable. The Insulin Tolerance Test (ITT) is generally considered the gold standard test for evaluation of growth hormone (GH) deficiency. The ITT involves giving insulin intravenously (through a plastic tube inserted in your vein) to lower your blood sugar followed by the collection of blood samples to evaluate how your body handles low blood sugar. There are side effects of the ITT including hypoglycemia (low blood sugar causing you to become weak, perspire, shaky and have some mental cloudiness) which can be unpleasant. ITT can not be performed in patients older than 65 years of age and in those with certain medical conditions such as history of heart disease, seizure disorder or stroke. At the same time, the ITT needs to be done by an experienced clinician and requires trained staff to perform. For this reason there is a need for an alternative reliable test for evaluation of GHD.
The second purpose of this study is to find out if you have adrenal insufficiency. Cortisol is a hormone produced by the adrenal gland and is released in response to stress. Cortisol production is regulated through the hypothalamus and the pituitary gland. Its primary functions are to increase blood sugar, regulate the immune system and aid in fat, protein and carbohydrate metabolism. Patients with low cortisol may experience fatigue, body ache, sleep disturbance, nausea and mood changes. Pituitary disorders may lead to low cortisol levels and can cause symptoms associated with adrenal insufficiency. The Insulin Tolerance Test (ITT) can also be used for the evaluation of adrenal function. Patients who can not undergo ITT, can be evaluated by the ACTH (adrenocorticotropic hormone) Stimulation Test, which is generally very well tolerated. Preliminary results from previous studies indicate that the Glucagon Stimulation Test (GST) may be used to evaluate adrenal function. The investigators in this study will compare your cortisol levels during two different GSTs with the cortisol levels achieved during ITT or ACTH stimulation test.
Since the 1970s, the Glucagon Stimulation Test (GST) has been used by several research studies for evaluation of GHD and adrenal insufficiency. Glucagon is a hormone produced in the pancreas and is secreted during times of low blood sugar or in response to growth hormone. It is used to raise very low blood sugar and in diagnostic testing of the stomach and other digestive organs. Glucagon is readily available, relatively inexpensive and generally well tolerated; the major side effects include upset stomach that can lead to vomiting and headaches. It can be used in patients with diabetes and those older than 65 years of age.
The glucagon stimulation test (GST) has been suggested as an alternative test to ITT for evaluation of growth hormone deficiency (GHD) and adrenal insufficiency. The test is similar to the ITT and ACTH Stimulation Test in that blood samples are taken both before and after the medication is given. Glucagon is given intramuscularly (as in injection in your muscle). The fewer side effects make this an attractive substitute for the ITT. The 2007 consensus guideline by the GH Research Society considers GST as a test that may be used for evaluation of patients suspected to have GHD. However, the same statement does not provide any diagnostic cut-off value for GH during the GST. The purpose of this study is to see if the GST can be an accurate substitute for the ITT in the evaluation of both GHD and adrenal insufficiency.
- Being tested
- Glucagon stimulation test and insulin tolerance test
- Keywords
- glucagon stimulation test, insulin tolerance test, growth hormone deficiency, hypothalamic-pituitary disorders
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon stimulation test and insulin tolerance testProcedure or surgery
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
glucagon stimulation test and insulin tolerance testProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: glucagon stimulation test and insulin tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Allegheny Endocrinology Associates, Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Amir Hamrahian, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282164
- Sponsor's protocol ID
- 10-810
- Acronym
- GST
- Status last verified
- May 2017
- First submitted
- 19 Jan 2011
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Accuracy of the Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and the Hypothalamic-Pituitary-Adrenal Axis
- ClinicalTrials.gov ID
- NCT01282164
- Acronym / sponsor ID
- GST / 10-810
- Keywords
- glucagon stimulation test, insulin tolerance test, growth hormone deficiency, hypothalamic-pituitary disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Allegheny Endocrinology Associates, Oregon Health and Science University
- Study start
- Jan 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Jan 2011 (estimated)
- Results
- Posted 5 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Growth hormone is a protein that is produced by the pituitary gland and influences the metabolism (how fast things work) of other proteins, carbohydrates, and fats in the body. This allows the growth hormone to help humans keep a healthy balance between fat, muscle and bone throughout their life. Some people have what is called Growth Hormone Deficiency (GHD), which means that they do not produce enough growth hormone. GHD may lead to a tendency to be fat, (especially around the abdominal area), a reduced ability to exercise, heart disease, an increased possibility of breaking bones, and a general reduced quality of life.
GHD is usually evaluated through growth hormone stimulation test(s). One of the most reliable tests to evaluate if someone has GHD is by using arginine + Growth Hormone Releasing Hormone (GHRH) test. However, Since 2008 GHRH is no longer available in the USA. For this reason there has been a significant gap for an alternative test for evaluation of patients suspected to have GHD that can be easily performed and be reliable. The Insulin Tolerance Test (ITT) is generally considered the gold standard test for evaluation of growth hormone (GH) deficiency. The ITT involves giving insulin intravenously (through a plastic tube inserted in your vein) to lower your blood sugar followed by the collection of blood samples to evaluate how your body handles low blood sugar. There are side effects of the ITT including hypoglycemia (low blood sugar causing you to become weak, perspire, shaky and have some mental cloudiness) which can be unpleasant. ITT can not be performed in patients older than 65 years of age and in those with certain medical conditions such as history of heart disease, seizure disorder or stroke. At the same time, the ITT needs to be done by an experienced clinician and requires trained staff to perform. For this reason there is a need for an alternative reliable test for evaluation of GHD.
The second purpose of this study is to find out if you have adrenal insufficiency. Cortisol is a hormone produced by the adrenal gland and is released in response to stress. Cortisol production is regulated through the hypothalamus and the pituitary gland. Its primary functions are to increase blood sugar, regulate the immune system and aid in fat, protein and carbohydrate metabolism. Patients with low cortisol may experience fatigue, body ache, sleep disturbance, nausea and mood changes. Pituitary disorders may lead to low cortisol levels and can cause symptoms associated with adrenal insufficiency. The Insulin Tolerance Test (ITT) can also be used for the evaluation of adrenal function. Patients who can not undergo ITT, can be evaluated by the ACTH (adrenocorticotropic hormone) Stimulation Test, which is generally very well tolerated. Preliminary results from previous studies indicate that the Glucagon Stimulation Test (GST) may be used to evaluate adrenal function. The investigators in this study will compare your cortisol levels during two different GSTs with the cortisol levels achieved during ITT or ACTH stimulation test.
Since the 1970s, the Glucagon Stimulation Test (GST) has been used by several research studies for evaluation of GHD and adrenal insufficiency. Glucagon is a hormone produced in the pancreas and is secreted during times of low blood sugar or in response to growth hormone. It is used to raise very low blood sugar and in diagnostic testing of the stomach and other digestive organs. Glucagon is readily available, relatively inexpensive and generally well tolerated; the major side effects include upset stomach that can lead to vomiting and headaches. It can be used in patients with diabetes and those older than 65 years of age.
The glucagon stimulation test (GST) has been suggested as an alternative test to ITT for evaluation of growth hormone deficiency (GHD) and adrenal insufficiency. The test is similar to the ITT and ACTH Stimulation Test in that blood samples are taken both before and after the medication is given. Glucagon is given intramuscularly (as in injection in your muscle). The fewer side effects make this an attractive substitute for the ITT. The 2007 consensus guideline by the GH Research Society considers GST as a test that may be used for evaluation of patients suspected to have GHD. However, the same statement does not provide any diagnostic cut-off value for GH during the GST. The purpose of this study is to see if the GST can be an accurate substitute for the ITT in the evaluation of both GHD and adrenal insufficiency.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study patients | Experimental | Procedure: Glucagon stimulation test and insulin tolerance testpatients with growth hormone deficiency or hypothalamic-pituitary disorders underwent fixed-dose glucagon stimulation test (GST), weight-based GST and insulin tolerance test (ITT). |
| Control | Active comparator | Procedure: glucagon stimulation test and insulin tolerance testThe 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (17 listed)
- unable to give consent
- pregnancy
- active acromegaly
- pheochromocytoma
- active Cushing's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucagon stimulation test and insulin tolerance testglucagon 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 | Procedure or surgery | Study patients |
| glucagon stimulation test and insulin tolerance testglucagon 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 | Procedure or surgery | Control |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Adult Growth Hormone Deficiency
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Recruiting
BELux Children OutcoME During A(@)Dulthood With GHD
Growth Hormone Deficiency, Adult Growth Hormone Deficiency
RecruitingObservational study
Charactertizing Growth Hormone Deficiency in Traumatic Brain Injury
Growth Hormone Deficiency, Traumatic Brain Injury
RecruitingPhase 2
Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency
Adult Growth Hormone Deficiency
Enrolling by invitationObservational study
A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
Adult Growth Hormone Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Hamrahian, MD principal investigator
The Cleveland Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucagon stimulation test and insulin tolerance test in people with Adult Growth Hormone Deficiency and Hypothalamic-pituitary Disorders, run by The Cleveland Clinic at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD). (time frame: one year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.