Growth Hormone DeficiencyNCT03500913

Adipose Tissue and Serum Inflammation in GH Deficiency

An observational study of Growth Hormone Deficiency, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will examine adipose tissue inflammation and adipokine expression and serum markers of inflammation and adipokine levels in patients with growth hormone (GH) deficiency before and after treatment. 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: 19 participants
Where: 1 siteUnited States
Study dates: 19 May 2019to 20 Feb 2020
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 growth hormone response < 3 ng/ml or 3 or more pituitary hormone deficiencies and 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 growth hormone 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 growth hormone 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 Irving Medical Center
New York, New York, 10032

Other trials in United States

About this study

Official title: Adipose Tissue and Serum Inflammation in Growth Hormone (GH) Deficiency

Read the detailed description

The GH axis has important influences on adipose tissue. Preliminary data from the investigators' study in acromegaly, a state of GH excess, suggests that GH reduces adipose tissue (AT) mass and serum inflammation. However, GH seems to reduce macrophage markers in adipose tissue yet increase adipocyte inflammation. This novel dissociation of macrophage and adipocyte inflammation is hypothesized to be due to GH. In order to examine this hypothesis further this study will examine adipose tissue and serum inflammation in patients with GH deficiency before and after GH therapy. The investigators will obtain subcutaneous adipose tissue by biopsy in patients with active GH deficiency planning to undergo therapy for GH deficiency. Concurrently serum samples will be taken for analysis of levels of inflammatory markers and adipokines. After treatment for 12 months with a normal levels of Insulin-like growth factor 1 (IGF-1), a marker of GH deficiency, patients will have a repeat adipose tissue biopsy. Adipose tissue parameters will be analyzed in each specimen and then compared to each patient over time as well as to body mass index (BMI)-matched control subjects.

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
Also called GH
Patients will receive growth hormone replacement therapy as per standard clinical care during this study.

Study groups in NCT03500913
Study group	Role	What they receive
Adults with growth hormone deficiency		Subjects who present to the neuroendocrine unit at Columbia University Irving Medical Center (CUIMC) for therapy of GH deficiency or who are followed in the unit and have active GH deficiency and are planning to initiate a therapy. Receives: Drug: Growth Hormone
Control group		Healthy subjects matched to the GH deficiency subjects for age (+/- 5 years), gender and total fat mass (+/- 4%).

What is being measured

The primary outcome is the main question the study is designed to answer.

Visceral Adipose Tissue (VAT) mass
Visceral adipose tissue mass as measured by tota body magnetic resonance imaging
Measured: Baseline to 12 months of GH therapy

Secondary outcomes (12)

Intra-hepatic lipid level
Intra-hepatic lipid level measured by magnetic resonance imaging of liver
Measured: Baseline to 12 months of GH therapy
Skeletal Muscle Mass
Skeletal muscle mass measured by total body magnetic resonance imaging
Measured: Baseline to 12 months of GH therapy
Total body fat
Total body fat as measured by dual x-ray absorptiometry
Measured: Baseline to 12 months of GH therapy
Resting metabolic rate
Resting metabolic rate
Measured: Baseline to 12 months of GH therapy
Relative gene expression of CD68 gene
Relative gene expression values of Cluster of Differentiation 68 (CD68) gene expression 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 (MCP-1) gene in adipose tissue
Measured: Baseline to 12 months of GH therapy
Relative gene expression IL6 gene
Relative gene expression Interleukin 6 (IL6) gene in adipose tissue
Measured: Baseline to after 12 months of treatment for GH deficiency
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
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
CRP 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.

19 May 201920 Feb 2020

First posted18 Apr 2018
Study start19 May 2019
Primary completion12 Feb 2020
Study completion20 Feb 2020

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: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03500913
Sponsor's protocol ID: AAAP3950
Other IDs: 1R01DK110771-01A1
Status last verified: May 2025
First submitted: 10 Apr 2018
Last updated: 13 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Growth Hormone Deficiency trials

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 Serum Inflammation in Growth Hormone (GH) Deficiency
ClinicalTrials.gov ID: NCT03500913
Acronym / sponsor ID: AAAP3950
Conditions: Growth Hormone Deficiency
Keywords: Growth Hormone Deficiency, Adipose Tissue, Inflammation
Study type: Observational
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 19 May 2019 (actual)
Primary completion: 12 Feb 2020 (actual)
Study completion: 20 Feb 2020 (actual)
First posted: 18 Apr 2018 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Adults with growth hormone deficiency	–	Drug: Growth HormoneSubjects who present to the neuroendocrine unit at Columbia University Irving Medical Center (CUIMC) for therapy of GH deficiency or who are followed in the unit and have active GH deficiency and are planning to initiate a therapy.
Control group	–	–Healthy subjects matched to the GH deficiency subjects for age (+/- 5 years), gender and total fat mass (+/- 4%).

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 growth hormone response < 3 ng/ml or 3 or more pituitary hormone deficiencies and 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 HormoneAlso: GHPatients will receive growth hormone replacement therapy as per standard clinical care during this study.	Drug	Adults with growth hormone deficiency

Primary outcome

Visceral Adipose Tissue (VAT) mass
Time frame: Baseline to 12 months of GH therapy
Visceral adipose tissue mass as measured by tota body magnetic resonance imaging

12 secondary outcomes

Intra-hepatic lipid level
Time frame: Baseline to 12 months of GH therapy
Skeletal Muscle Mass
Time frame: Baseline to 12 months of GH therapy
Total body fat
Time frame: Baseline to 12 months of GH therapy
Resting metabolic rate
Time frame: Baseline to 12 months of GH therapy
Relative gene expression of CD68 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 IL6 gene
Time frame: Baseline to after 12 months of treatment for GH deficiency
Relative gene expression values of CD11c gene
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
CRP 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

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.

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?

Visceral Adipose Tissue (VAT) mass (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?

On the ClinicalTrials.gov record for NCT03500913.

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.