Growth Hormone DeficiencyPhase 4NCT00720902
Adult Growth Hormone Deficiency and Cardiovascular Risk
A Phase 4 study testing Blood draws, growth hormone releasing hormone (GHRH) & arginine and Carotid ultrasound in people with Growth Hormone Deficiency, run by Columbia University at 1 site in United States.
Trial summary
This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Blood draws, growth hormone releasing hormone (GHRH) & arginine and Carotid ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to May 2011
- Phase
- Phase 4
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 19 years or older who have undergone transsphenoidal surgery for a clinically non-secreting pituitary adenoma
Who cannot join
- Currently taking growth hormone, radiation therapy in the past 5 years, changes in dose of other pituitary hormone replacement therapy in past 3 months, taking hydrocortisone (or its equivalent) at a dose of > 30 mg/day, pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University, College of Physicians and Surgeons
New York, New York, 10032
About this study
Official title: Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas
This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize that adults with growth hormone deficiency will have results suggestive of an increased risk for cardiovascular disease.
Read the detailed description
Subjects will first be tested for possible growth hormone deficiency. This will be done by administering two intravenous medications that should stimulate growth hormone secretion and we will measure growth hormone in the blood every 30 minutes following the administration. Once we have the results on enough subjects we will split the cohort into those subjects who are growth hormone deficient and those who have normal growth hormone. The two groups will each undergo various tests all designed to assess some component of cardiovascular risk. Ultimately we will compare the results of each test to see if those who are growth hormone deficient have an increased risk for cardiovascular disease.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Blood draws, growth hormone releasing hormone (GHRH) & arginine, Carotid ultrasound, MRI, Endothelial cell biopsy
- Keywords
- Growth hormone
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawsProcedure or surgery
Subjects will have serum cardiovascular markers assessed
growth hormone releasing hormone (GHRH) & arginineDrug
Subjects will receive GHRH and arginine intravenously and then have blood drawn at frequent intervals over a 90 minutes to assess growth hormone secretion.
Carotid ultrasoundProcedure or surgery
Subjects will have an ultrasound of their neck to assess their carotid arteries to look for intima-medial thickness.
MRIProcedure or surgery
Subjects will have MRI and MR spectroscopy of the abdomen and lower extremities to assess for fat in internal organs and muscle.
Endothelial cell biopsyProcedure or surgery
Subjects will undergo endothelial cell biopsies to harvest endothelial cells to study. It will occur once and takes approximately 20 minutes. Patients will have an iv placed and then a sterile wire is passed back and forth in the iv a couple of times. Three wires are passed.
| Study group | Role | What they receive |
|---|---|---|
| A - Normal growth hormone secretion | Active comparator | Patients who have undergone transsphenoidal surgery for a pituitary adenoma and have normal growth hormone secretion: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) \& arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy. Receives: Procedure: Blood draws; Drug: growth hormone releasing hormone (GHRH) & arginine; Procedure: Carotid ultrasound; Procedure: MRI; Procedure: Endothelial cell biopsy |
| B - Growth hormone deficient | Active comparator | Patients who have undergone transsphenoidal surgery for pituitary adenoma who are growth hormone deficient: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) \& arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy. Receives: Procedure: Blood draws; Drug: growth hormone releasing hormone (GHRH) & arginine; Procedure: Carotid ultrasound; Procedure: MRI; Procedure: Endothelial cell biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive Protein (CRP) Levels
C-reactive protein (CRP) levels in GH sufficient and GH deficient participants
Measured: Day 1
Homocysteine Level
Homocytsteine levels in GH sufficient and GH deficient participants
Measured: Day 1
Total Cholesterol Level
Total cholesterol levels in GH sufficient and GH deficient participants
Measured: Day 1
Secondary outcomes (8)
Percentage of Fat Measured by DXA DEXA
Percentage of total body fat and trunk fat as measured by DXA
Measured: Day 1
Lean Body Mass by DXA DEXA
Lean body mass as measured by DXA
Measured: Day 1
Insulin Sensitivity as Assessed by Fasting Insulin Levels
Insulin sensitivity as assessed by fasting insulin levels
Measured: Day 1
Glucose Levels as Assessed by an Oral Glucose Tolerance Test
Glucose levels as assessed by an oral glucose tolerance test
Measured: Day 1
Endothelial Function as Assessed by Flow Mediated Dilatation and Endothelial Cell Biopsy
Endothelial function as assessed by flow mediated dilatation and endothelial cell biopsy for measurement of inflammatory markers.
Measured: Day 1
Carotid Intimal-medial Thickness Studies as Assessed by Ultrasound
Carotid intimal-medial thickness studies will be measured by ultrasound
Measured: Year 1
Intramyocellular Lipid Content Using MRI and MR Spectroscopy
Intramyocellular lipid content using MRI and MR spectroscopy of the soleus muscle was performed.
Measured: Day 1
Intrahepatic Lipid Content Using MRI and MR Spectroscopy
Intrahepatic lipid (IHL) content using MRI and MR spectroscopy of the liver was performed.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startFeb 2007
- Primary completionMar 2010
- Study completionMay 2011
Why it stopped: poor enrollment
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 Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela U. Freda, Columbia University
- Investigators
- John C Ausiello, MD, Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720902
- Sponsor's protocol ID
- AAAB9681 (Serono-001)
- Other IDs
- Serono-001
- Status last verified
- Oct 2022
- First submitted
- 16 Jun 2008
- Last updated
- 16 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas
- ClinicalTrials.gov ID
- NCT00720902
- Acronym / sponsor ID
- AAAB9681 (Serono-001)
- Conditions
- Growth Hormone Deficiency
- Keywords
- Growth hormone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Jul 2008 (estimated)
- Results
- Posted 16 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize that adults with growth hormone deficiency will have results suggestive of an increased risk for cardiovascular disease.
Detailed description
Subjects will first be tested for possible growth hormone deficiency. This will be done by administering two intravenous medications that should stimulate growth hormone secretion and we will measure growth hormone in the blood every 30 minutes following the administration. Once we have the results on enough subjects we will split the cohort into those subjects who are growth hormone deficient and those who have normal growth hormone. The two groups will each undergo various tests all designed to assess some component of cardiovascular risk. Ultimately we will compare the results of each test to see if those who are growth hormone deficient have an increased risk for cardiovascular disease.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Normal growth hormone secretion | Active comparator | Procedure: Blood draws, Drug: growth hormone releasing hormone (GHRH) & arginine, Procedure: Carotid ultrasound, Procedure: MRI, Procedure: Endothelial cell biopsyPatients who have undergone transsphenoidal surgery for a pituitary adenoma and have normal growth hormone secretion: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) \& arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy. |
| B - Growth hormone deficient | Active comparator | Procedure: Blood draws, Drug: growth hormone releasing hormone (GHRH) & arginine, Procedure: Carotid ultrasound, Procedure: MRI, Procedure: Endothelial cell biopsyPatients who have undergone transsphenoidal surgery for pituitary adenoma who are growth hormone deficient: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) \& arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults 19 years or older who have undergone transsphenoidal surgery for a clinically non-secreting pituitary adenoma
Key exclusion criteria (1 listed)
- Currently taking growth hormone, radiation therapy in the past 5 years, changes in dose of other pituitary hormone replacement therapy in past 3 months, taking hydrocortisone (or its equivalent) at a dose of > 30 mg/day, pregnant or nursing women
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 |
|---|---|---|
| Blood drawsSubjects will have serum cardiovascular markers assessed | Procedure or surgery | A - Normal growth hormone secretion, B - Growth hormone deficient |
| growth hormone releasing hormone (GHRH) & arginineSubjects will receive GHRH and arginine intravenously and then have blood drawn at frequent intervals over a 90 minutes to assess growth hormone secretion. | Drug | A - Normal growth hormone secretion, B - Growth hormone deficient |
| Carotid ultrasoundSubjects will have an ultrasound of their neck to assess their carotid arteries to look for intima-medial thickness. | Procedure or surgery | A - Normal growth hormone secretion, B - Growth hormone deficient |
| MRISubjects will have MRI and MR spectroscopy of the abdomen and lower extremities to assess for fat in internal organs and muscle. | Procedure or surgery | A - Normal growth hormone secretion, B - Growth hormone deficient |
| Endothelial cell biopsySubjects will undergo endothelial cell biopsies to harvest endothelial cells to study. It will occur once and takes approximately 20 minutes. Patients will have an iv placed and then a sterile wire is passed back and forth in the iv a couple of times. Three wires are passed. | Procedure or surgery | A - Normal growth hormone secretion, B - Growth hormone deficient |
Primary outcome
C-reactive Protein (CRP) Levels
Time frame: Day 1
C-reactive protein (CRP) levels in GH sufficient and GH deficient participants
Homocysteine Level
Time frame: Day 1
Homocytsteine levels in GH sufficient and GH deficient participants
Total Cholesterol Level
Time frame: Day 1
Total cholesterol levels in GH sufficient and GH deficient participants
8 secondary outcomes
Percentage of Fat Measured by DXA DEXA
Time frame: Day 1
Lean Body Mass by DXA DEXA
Time frame: Day 1
Insulin Sensitivity as Assessed by Fasting Insulin Levels
Time frame: Day 1
Glucose Levels as Assessed by an Oral Glucose Tolerance Test
Time frame: Day 1
Endothelial Function as Assessed by Flow Mediated Dilatation and Endothelial Cell Biopsy
Time frame: Day 1
Carotid Intimal-medial Thickness Studies as Assessed by Ultrasound
Time frame: Year 1
Intramyocellular Lipid Content Using MRI and MR Spectroscopy
Time frame: Day 1
Intrahepatic Lipid Content Using MRI and MR Spectroscopy
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Growth Hormone Deficiency
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
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
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
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.
John C Ausiello, MD study director
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood draws, growth hormone releasing hormone (GHRH) & arginine and Carotid ultrasound in people with Growth Hormone Deficiency, run by Columbia University at 1 site 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2022). 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?
C-reactive Protein (CRP) Levels (time frame: Day 1). The study lists 3 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 16 Nov 2022.