A Phase 4 interventional study of Blood draws and growth hormone releasing hormone (GHRH) & arginine in Growth Hormone Deficiency, sponsored by Columbia University. Terminated at 1 site in United States. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-11-16.
Sponsored by Columbia University · Phase 4, Interventional, and Other
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.
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.
164 studies on the registry are indexed under Dwarfism, Pituitary; 25 are open to participants now.
This study's enrollment of 7 is below the median of 72 across 122 interventional studies indexed under Dwarfism, Pituitary.
Browse Dwarfism, Pituitary studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Blood draws · Drug: growth hormone releasing hormone (GHRH) & arginine · Procedure: Carotid ultrasound · Procedure: MRI · Procedure: Endothelial cell biopsy
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.
Procedure: Blood draws · Drug: growth hormone releasing hormone (GHRH) & arginine · Procedure: Carotid ultrasound · Procedure: MRI · Procedure: Endothelial cell biopsy
Subjects will have serum cardiovascular markers assessed
Subjects will receive GHRH and arginine intravenously and then have blood drawn at frequent intervals over a 90 minutes to assess growth hormone secretion.
Subjects will have an ultrasound of their neck to assess their carotid arteries to look for intima-medial thickness.
Subjects will have MRI and MR spectroscopy of the abdomen and lower extremities to assess for fat in internal organs and muscle.
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.
C-reactive Protein (CRP) Levels
C-reactive protein (CRP) levels in GH sufficient and GH deficient participants
Time frame: Day 1
Homocysteine Level
Homocytsteine levels in GH sufficient and GH deficient participants
Time frame: Day 1
Total Cholesterol Level
Total cholesterol levels in GH sufficient and GH deficient participants
Time frame: Day 1
Percentage of Fat Measured by DXA DEXA
Percentage of total body fat and trunk fat as measured by DXA
Time frame: Day 1
Lean Body Mass by DXA DEXA
Lean body mass as measured by DXA
Time frame: Day 1
Insulin Sensitivity as Assessed by Fasting Insulin Levels
Insulin sensitivity as assessed by fasting insulin levels
Time frame: Day 1
Glucose Levels as Assessed by an Oral Glucose Tolerance Test
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
Endothelial function as assessed by flow mediated dilatation and endothelial cell biopsy for measurement of inflammatory markers.
Time frame: Day 1
Carotid Intimal-medial Thickness Studies as Assessed by Ultrasound
Carotid intimal-medial thickness studies will be measured by ultrasound
Time frame: Year 1
Intramyocellular Lipid Content Using MRI and MR Spectroscopy
Intramyocellular lipid content using MRI and MR spectroscopy of the soleus muscle was performed.
Time frame: Day 1
Intrahepatic Lipid Content Using MRI and MR Spectroscopy
Intrahepatic lipid (IHL) content using MRI and MR spectroscopy of the liver was performed.
Time frame: Day 1
| Milestone | Growth Hormone (GH) Sufficient Participants | Growth Hormone (GH) Deficient Participants |
|---|---|---|
| Started | 4 | 3 |
| Completed | 0 | 3 |
| Not completed | 4 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Unable to perform testing, lack of test agent and the study terminated | 3 | 0 |
C-reactive protein (CRP) levels in GH sufficient and GH deficient participants
| ng/dL | GH Sufficient Participants | GH Deficient Participants |
|---|---|---|
| C-reactive Protein (CRP) Levels | — | 14.46 ± 14.90 |
Homocytsteine levels in GH sufficient and GH deficient participants
| micromol/L | GH Sufficient Participants | GH Deficient Participants |
|---|---|---|
| Homocysteine Level | — | 8.04 ± 0.90 |
Total cholesterol levels in GH sufficient and GH deficient participants
| mg/dL | GH Sufficient Participants | GH Deficient Participants |
|---|---|---|
| Total Cholesterol Level | — | 271 ± 90.5 |
Percentage of total body fat and trunk fat as measured by DXA
| Percent | GH Sufficient Participants | GH Deficient Participants |
|---|---|---|
| Total body fat | — | 42.33333333 ± 8.73 |
| Trunk fat | — | 21 ± 3.60 |
Lean body mass as measured by DXA
| kg | GH Sufficient Participants | GH Deficient Participants |
|---|---|---|
| Lean Body Mass by DXA DEXA | — | 46.67 ± 2.89 |
Insulin sensitivity as assessed by fasting insulin levels
| mIU/L | GH Sufficient Participants | GH Deficient Participants |
|---|---|---|
| Insulin Sensitivity as Assessed by Fasting Insulin Levels | — | 35.5 ± 28.94 |
Glucose levels as assessed by an oral glucose tolerance test
| mg/dL | GH Sufficient Participants | GH Deficient Participants |
|---|---|---|
| Glucose Levels as Assessed by an Oral Glucose Tolerance Test | — | 91.33 ± 4.163 |
Endothelial function as assessed by flow mediated dilatation and endothelial cell biopsy for measurement of inflammatory markers.
No measurements were reported for this outcome.
Carotid intimal-medial thickness studies will be measured by ultrasound
No measurements were reported for this outcome.
Intramyocellular lipid content using MRI and MR spectroscopy of the soleus muscle was performed.
| Percent water signal | GH Sufficient Participants | GH Deficient Participants |
|---|---|---|
| Intramyocellular Lipid Content Using MRI and MR Spectroscopy | — | 0.011763 ± 0.00159 |
Intrahepatic lipid (IHL) content using MRI and MR spectroscopy of the liver was performed.
| Percent water signal | GH Sufficient Participants | GH Deficient Participants |
|---|---|---|
| Intrahepatic Lipid Content Using MRI and MR Spectroscopy | — | 9.97 ± 7.17 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GH Sufficient Participants | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| GH Deficient Participants | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | GH Sufficient Participants | GH Deficient Participants | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 3 | 7 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | GH Sufficient Participants | GH Deficient Participants | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 2 | 3 | 5 |
| Race (NIH/OMB)(Participants) | GH Sufficient Participants | GH Deficient Participants | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 3 | 1 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
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