Growth Hormone DeficiencyNCT03225755
Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy
An observational study of Growth Hormone Deficiency, run by Columbia University at 1 site in United States.
Trial summary
In order to examine the effect of GH on adipose tissue inflammation, this study will examine adipose tissue and serum inflammation in patients with GH deficiency before and after GH therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Growth hormone
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential subjects include all those who present to our Neuroendocrine Unit for therapy of GH deficiency or who are followed in our unit and have GH deficiency and are planning to initiate a therapy. Subjects will be those with central adiposity. We expect are study group to be approximately half women and reflect the ethnic mix of our study populations of our other pituitary tumor studies, which is primarily drawn from the New York Metropolitan area.
Who may be able to join
- Males or females age ≥18 years with diagnosis of GH deficiency that is Adult Onset, either alone or associated with multiple pituitary hormone deficiencies and due to pituitary disease,hypothalamic disease, surgery, radiation therapy or Childhood Onset due to congenital, genetic, acquired, or idiopathic causes.
- Diagnosis of GH deficiency defined by: insulin tolerance test or glucagon test: peak GH response < 3 ng/ml or 3 or more pituitary hormone deficiencies and insulin-like growth factor 1 (IGF-1) standard deviation score < -2.0
- No history of diabetes mellitus and fasting blood sugar at screening visit ≤ 120 mg/dl.
- If patients have undergone surgical resection of a pituitary adenoma, a minimum of 12 months must have elapsed post surgery prior to enrollment and tumor will be demonstrated to be unchanged for 12 months or longer since surgery.
- May have a history of radiotherapy, but they must have completed their course of radiotherapy more than 3 months prior to study screening.
- If prior GH therapy must have not received prior GH replacement therapy in 310 the 6 months prior to screening.
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- Stable pituitary hormone supplements (x 3 months) prior to baseline visit and normal levels of free thyroxine, testosterone in males and normal adrenal function if not on replacement therapy.
- If female, a. Not pregnant (as evidenced by a negative serum pregnancy test) or lactating and b. If of childbearing potential, agrees to use a medically acceptable form of contraception (such as oral, implantable, or barrier contraception) from the time of screening, for the duration of the study, and for at least one month after study discontinuation or completion. Childbearing potential is defined as women who are not surgically sterile or not at least one year postmenopausal.
- Sign and date an informed consent document indicating that the subject (or legally acceptable representative) has been informed of and agrees to all pertinent aspects of the trial.
Who cannot join
- Have other conditions that may result in abnormal GH and/or IGF-I concentrations (e.g., severe hepatic disease, severe renal disease, malnutrition, treatment with levodopa).
- Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≥ 2 x upper limit of normal or clinically significant hepatic disease or renal impairment defined as creatinine > 1.5x upper normal.
- Have a pituitary adenoma with a distance to the optic chiasm of 5 mm or less, confirmed by a recent MRI scan (within two months prior to the screening visit).
- Pituitary tumor growth within the 12 months prior to study entry.
- GH therapy within 6 months of screening.
- Diabetes mellitus.
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- History of acromegaly.
- History of active Cushing's disease within 24 months of screening
- Visual field defects or other neurological symptoms due to current tumor mass compression.
- Have known or suspected drug or alcohol abuse.
- Have received an investigational medication within four weeks prior to Screening or is scheduled to receive any investigational medication during the study.
- Do not have the ability to fully comprehend the nature of the study, to follow instructions, cooperate with study procedures, and/or are unable to adhere to the visit scheduled outlined in the protocol.
- Have other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- History of a malignancy other than squamous or basal cell skin carcinoma that has been excised or intracranial malignant tumors or leukemia within 5 years of screening.
- Patients who have a known hypersensitivity to GH therapy
- Use of weight 349 loss medications
- Females who plan to change estrogen therapy during the trial
- Patients who have received supraphysiologic doses of glucocorticoids within the past 6 months (except for peri-operative (< 3 days duration) of dexamethasone), or who are currently receiving any chemotherapeutic agents.
- Patients who have received other investigational drugs administered or received within 30 days of study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuroendocrine Unit and Pituitary Center, Columbia University
New York, New York, 10032
About this study
In order to examine the effect of GH on adipose tissue inflammation, this study will examine adipose tissue and serum inflammation in patients with GH deficiency before and after GH therapy. The investigators will also obtain serum samples before and after treatment for adipokines, inflammatory markers and examine macrophages in circulation with regard to their inflammatory state. The investigators will also obtain adipose tissue biopsies from healthy subjects matched to the growth hormone deficiency (GHD) subjects. Adipose tissue specimens will be analyzed for adipose tissue morphology, adipocyte size, adipokine gene expression, and adipose tissue macrophage number.
Read the detailed description
The growth hormone (GH) axis has important influences on adipose tissue. GH may have a novel effect to reduce macrophage yet increase adipocyte inflammation in adipose tissue along with reducing adipose tissue mass. Disordered adipose tissue metabolism may dysregulate adipokine secretion, which could contribute to metabolic abnormalities in GH deficiency. Adipokines, peptides expressed and secreted by adipose tissue, exert important local adipose tissue and systemic metabolic effects. This study will combine direct assessment of adipose tissue with assessment of body composition. Adult GHD can be associated with central adiposity, insulin resistance, dyslipidemia and increased cardiovascular (CV) risk.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Growth hormone
- Keywords
- Growth Hormone Deficiency, Adipose Tissue, Inflammation
- Medical subject headings
- Dwarfism, Pituitary, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormoneDrug
Patients will receive growth hormone replacement therapy as per standard clinical care during this study.
| Study group | Role | What they receive |
|---|---|---|
| Adults with growth hormone deficiency | 12 subjects with GH deficiency, adult or childhood onset, and not currently on GH therapy will be studied. Subjects enrolled will be those planning GH therapy and beginning this therapy as part of their routine clinical care. Subjects will be 50% female and all subjects will be on 3 months of stable hormone replacements prior to testing. Receives: Drug: Growth hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative gene expression values of CD68 gene
Relative gene expression values of cluster of differentiation (CD68) gene in adipose tissue
Measured: Baseline to 12 months of GH therapy
Secondary outcomes (10)
Relative gene expression IL6 gene
Relative gene expression interleukin 6 (IL6) gene in adipose tissue
Measured: Baseline to 12 months of GH therapy
Relative gene expression values of MCP1 gene
Relative gene expression values of monocyte chemoattractant protein-1 (MCP1) gene in adipose tissue
Measured: Baseline to 12 months of GH therapy
Relative gene expression values of CD11c gene
Relative gene expression values of CD11c gene in adipose tissue
Measured: Baseline to 12 months of GH therapy
Visceral Adipose Tissue (VAT) mass
Visceral Adipose Tissue (VAT) mass as measured by magnetic resonance imaging of abdomen
Measured: Baseline to 12 months of GH therapy
Intra-hepatic lipid level
Intra-hepatic lipid level measured by magnetic resonance imaging of liver
Measured: Baseline to 12 months of GH therapy
Resting metabolic rate
Resting metabolic rate
Measured: Baseline to 12 months of GH therapy
Interleukin 6 (IL-6) level
Plasma level of interleukin 6 (IL-6)
Measured: Baseline to 12 months of GH therapy
TNFα level
Plasma level of tumor necrosis factor alpha (TNFα)
Measured: Baseline to 12 months of GH therapy
C-reactive protein level
Plasma level of c-reactive protein (CRP)
Measured: Baseline to 12 months of GH therapy
Homocysteine level
Plasma level of homocysteine
Measured: Baseline to 12 months of GH therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Aug 2017
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Pamela U. Freda, Columbia University
- Investigators
- Pamela U. Freda, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225755
- Sponsor's protocol ID
- AAAR3797
- Status last verified
- May 2025
- First submitted
- 19 Jul 2017
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy
- ClinicalTrials.gov ID
- NCT03225755
- Acronym / sponsor ID
- AAAR3797
- Conditions
- Growth Hormone Deficiency
- Keywords
- Growth Hormone Deficiency, Adipose Tissue, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to examine the effect of GH on adipose tissue inflammation, this study will examine adipose tissue and serum inflammation in patients with GH deficiency before and after GH therapy. The investigators will also obtain serum samples before and after treatment for adipokines, inflammatory markers and examine macrophages in circulation with regard to their inflammatory state. The investigators will also obtain adipose tissue biopsies from healthy subjects matched to the growth hormone deficiency (GHD) subjects. Adipose tissue specimens will be analyzed for adipose tissue morphology, adipocyte size, adipokine gene expression, and adipose tissue macrophage number.
Detailed description
The growth hormone (GH) axis has important influences on adipose tissue. GH may have a novel effect to reduce macrophage yet increase adipocyte inflammation in adipose tissue along with reducing adipose tissue mass. Disordered adipose tissue metabolism may dysregulate adipokine secretion, which could contribute to metabolic abnormalities in GH deficiency. Adipokines, peptides expressed and secreted by adipose tissue, exert important local adipose tissue and systemic metabolic effects. This study will combine direct assessment of adipose tissue with assessment of body composition. Adult GHD can be associated with central adiposity, insulin resistance, dyslipidemia and increased cardiovascular (CV) risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with growth hormone deficiency | – | Drug: Growth hormone12 subjects with GH deficiency, adult or childhood onset, and not currently on GH therapy will be studied. Subjects enrolled will be those planning GH therapy and beginning this therapy as part of their routine clinical care. Subjects will be 50% female and all subjects will be on 3 months of stable hormone replacements prior to testing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential subjects include all those who present to our Neuroendocrine Unit for therapy of GH deficiency or who are followed in our unit and have GH deficiency and are planning to initiate a therapy. Subjects will be those with central adiposity. We expect are study group to be approximately half women and reflect the ethnic mix of our study populations of our other pituitary tumor studies, which is primarily drawn from the New York Metropolitan area.
Key inclusion criteria (9 listed)
- Males or females age ≥18 years with diagnosis of GH deficiency that is Adult Onset, either alone or associated with multiple pituitary hormone deficiencies and due to pituitary disease,hypothalamic disease, surgery, radiation therapy or Childhood Onset due to congenital, genetic, acquired, or idiopathic causes.
- Diagnosis of GH deficiency defined by: insulin tolerance test or glucagon test: peak GH response < 3 ng/ml or 3 or more pituitary hormone deficiencies and insulin-like growth factor 1 (IGF-1) standard deviation score < -2.0
- No history of diabetes mellitus and fasting blood sugar at screening visit ≤ 120 mg/dl.
- If patients have undergone surgical resection of a pituitary adenoma, a minimum of 12 months must have elapsed post surgery prior to enrollment and tumor will be demonstrated to be unchanged for 12 months or longer since surgery.
- May have a history of radiotherapy, but they must have completed their course of radiotherapy more than 3 months prior to study screening.
Key exclusion criteria (19 listed)
- Have other conditions that may result in abnormal GH and/or IGF-I concentrations (e.g., severe hepatic disease, severe renal disease, malnutrition, treatment with levodopa).
- Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≥ 2 x upper limit of normal or clinically significant hepatic disease or renal impairment defined as creatinine > 1.5x upper normal.
- Have a pituitary adenoma with a distance to the optic chiasm of 5 mm or less, confirmed by a recent MRI scan (within two months prior to the screening visit).
- Pituitary tumor growth within the 12 months prior to study entry.
- GH therapy within 6 months of screening.
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 |
|---|---|---|
| Growth hormonePatients will receive growth hormone replacement therapy as per standard clinical care during this study. | Drug | Adults with growth hormone deficiency |
Primary outcome
Relative gene expression values of CD68 gene
Time frame: Baseline to 12 months of GH therapy
Relative gene expression values of cluster of differentiation (CD68) gene in adipose tissue
10 secondary outcomes
Relative gene expression IL6 gene
Time frame: Baseline to 12 months of GH therapy
Relative gene expression values of MCP1 gene
Time frame: Baseline to 12 months of GH therapy
Relative gene expression values of CD11c gene
Time frame: Baseline to 12 months of GH therapy
Visceral Adipose Tissue (VAT) mass
Time frame: Baseline to 12 months of GH therapy
Intra-hepatic lipid level
Time frame: Baseline to 12 months of GH therapy
Resting metabolic rate
Time frame: Baseline to 12 months of GH therapy
Interleukin 6 (IL-6) level
Time frame: Baseline to 12 months of GH therapy
TNFα level
Time frame: Baseline to 12 months of GH therapy
C-reactive protein level
Time frame: Baseline to 12 months of GH therapy
Homocysteine level
Time frame: Baseline to 12 months of GH therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Undecided
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Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
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RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
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Enrolling by invitationObservational study
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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.
Pamela U. Freda, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 9 inclusion and 19 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 13 May 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relative gene expression values of CD68 gene (time frame: Baseline to 12 months of GH therapy). 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 13 May 2025.