Healthy VolunteersPhase 1NCT00663611
Growth Hormone Administration and the Human Immune System
A Phase 1 study testing Norditropin in people with Healthy Volunteers, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
Background: In elderly individuals, an age-associated decline in the immune system s ability to function is believed to contribute to increased incidence of infection, autoimmune disorders, and cancer. Read more about this study
- Who is it for?
- Ages 25 to 50 years, men only
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Norditropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2006to 6 Oct 2014
- Phase
- Phase 1
- 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 25 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy men only (There is a gender difference in GH response with adult females requiring on average twice the GH dose for similar effects. In order to eliminate gender difference as a confounding factor in this study, we are studying male subjects only because the GH dose requirement is lower.)
- Age 25-50 (Age restriction is used to remove age as a confounding factor because GH and thymic function are known to decrease with age.)
- Screening laboratory evaluations with no clinically significant abnormal results (minor deviations from "normal" lab results will be at the discretion of the principal investigator):
- fasting comprehensive metabolic panel
- complete blood count with differential and platelets
- 75-gram oral glucose tolerance test (OGTT)
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- fasting plasma glucose (FPG) < 100 mg/dL
- 2-hr OGTT < 140 mg/dL
- Insulin-like growth factor-I (IGF-I)
- thyroid function test (TSH, free T3, free T4)
- fasting lipid profile
- BMI < 30 (Men with BMI >= 30 are excluded because decrease in GH secretion and clearance has been shown in obesity.)
- Have NOT participated in another clinical trial involving any pharmacologic agents within the past 60 days
- Able to complete an inform consent
- Agree to not participate in other clinical trials within the study period
Who cannot join
- Women
- FPG >= 100 mg/dL or 2-hour OGTT >= 140 mg/dL
- Abnormal electrocardiogram (EKG) suggesting possible underlying cardiac conditions that, in the opinion of the investigator(s), may cause participation of the subject in the study unsafe
- Positive stool guaiac
- Evidence of illicit drug use
- History of smoking any tobacco products within one year prior to screening
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- Alcohol intake > 30 grams (drink more than 2 beers per day OR equivalent amount of alcohol)
- History of Human Immunodeficiency Virus (HIV) infection
- History of active or chronic Hepatitis B and/or C infection
- History of malignancy
- History of coronary disease
- History of seizures or other neurologic diseases
- History of liver or renal diseases
- History of gastrointestinal or endocrine disorders
- History of glucocorticoid use (over one month) or other immunosuppressive agents (any)
- unable to undergo a magnetic resonance imaging (MRI) procedure
- Any medical history that, in the opinion of the investigator(s), will make participation of the subject in the study unsafe
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
About this study
Background:
- In elderly individuals, an age-associated decline in the immune system s ability to function is believed to contribute to increased incidence of infection, autoimmune disorders, and cancer. This decline in immune system function may be related to the decline in the body s production of growth hormone, which helps regulate human development and may contribute to the health of the immune system. Researchers are interested in studying whether growth hormone, given as an infusion over time, can improve the function of the immune system and other body systems associated with good health.
Read more
Objectives:
- To study the effects of growth hormone administration on the immune systems of healthy men.
Eligibility:
- Healthy men between 25 and 50 years of age.
Design:
- This protocol will involve three separate studies: Study I, Study IB, and Study II. Participants in Study I and Study IB may participate in Study II as directed by the researchers.
- Participants will be screened with a full medical history and physical examination, and will provide blood, urine, and stool samples; have a glucose tolerance test; and have other tests as required by the researchers.
- Participants will have an infusion pump with a small catheter inserted beneath the skin to administer the study chemicals (either growth hormone or placebo).
- Study I and Study IB participants will receive pulses of growth hormone through the infusion pump at regular intervals to monitor the body s response to the hormone. Study IB participants will receive a higher dose of growth hormone than Study I participants.
- Throughout the study period, all participants will have frequent blood and urine tests, as well as tests of glucose tolerance and metabolism, imaging studies, and other tests as required by the researchers.
- Study II participants will be divided into two groups. The first group will receive pulses of either growth hormone or placebo infusion at intervals throughout the day for 4 weeks, followed by an 8-week period without infusions. The second group will receive conventional once-a-day infusion of growth hormone or placebo for 4 weeks, followed by an 8-week period without infusions.
- Throughout the study period, all participants will have frequent blood and urine tests, as well as tests of glucose tolerance and metabolism, imaging studies, and other tests as required by the researchers.
Read the detailed description
Objectives and Specific Aims:
We plan to investigate whether growth hormone, administered in a physiological or pulsatile fashion, can elicit relevant changes in the human immune system while at the same time associated with no change or even an improvement in the metabolic profiles such as insulin sensitivity.
Experimental Design and Methods:
Thirty-eight healthy men, age 25-50, will be recruited for this study. There are three parts to this study: Study I, Study IB and Study II. Study I and IB each involve six subjects and are designed to test the hypothesis that pulsatile subcutaneous infusion of GH via a subcutaneous infusion pump yields a reasonable pulsatile GH pattern. The dose of GH used in Study IB is three-fold higher than in Study I. Study I and IB are done first before proceeding to Study II.
Study II is a randomized, double-blinded, placebo-controlled 12-week study involving 26 subjects divided into 2 groups: Group A and Group B. Group A involves 13 subjects receiving pulsatile GH or placebo infusion for 4 weeks with 8-week washout after intervention. Group B involves 13 subjects receiving conventional once a day subcutaneous infusion of GH or placebo for 4 weeks with 8-week washout after intervention.
Medical Relevance and Expected Outcome:
This study ascertains the significance of the effect of pulsatile growth hormone administration on the human immune system and metabolic profile.
- Conditions
- Healthy Volunteers
- Being tested
- Norditropin, Placebo
- Keywords
- Immune Function, Metabolism, Pulsatile Growth Hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorditropinDrug
Norditropin (somatropin, rDNA origin) is a polypeptide hormone of recombinant DNA origin. The amino acid sequence of the product is identical to that of the human growth hormone of pituitary origin.
PlaceboDrug
0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| Study I and IB | Experimental | Each involve six subjects and are designed to test the hypothesis that pulsatile subcutaneous infusion of GH via a subcutaneous infusion pump will yield a reasonable pulsatile GH pattern. The dose of GH used in Study IB will be three-fold higher than that in Study I. Study I and IB will be done first before proceeding to Study II Receives: Drug: Norditropin |
| Study II | Experimental | Is a randomized, double-blinded, placebo-controlled 12 week study involving 26 subjects divided into 2 groups: Group A and Group B. Group A will involve 13 subjects receiving pulsatile GH or placebo infusion for 4 weeks with 8 week washout after intervention. Group B will involve 13 subjects receiving conventional once a day subcutaneous infusion of GH or placebo for 4 weeks with 8 week washout after intervention. Receives: Drug: Norditropin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
GH administration may elicit clinical significant and relevant changes in the human immune system
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study start19 Oct 2006
- Primary completion6 Oct 2014
- Study completion6 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Chee W Chia, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663611
- Sponsor's protocol ID
- 999907260
- Other IDs
- 07-AG-N260
- Status last verified
- 11 Mar 2026
- First submitted
- 21 Apr 2008
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The NIA IRP is discussing the plan to make IPD available. A final decision has not been made.
Publications
Bar-Dayan Y, Small M. Effect of bovine growth hormone administration on the pattern of thymic involution in mice. Thymus. 1994;23(2):95-101.
PubMed 7725388Napolitano LA, Lo JC, Gotway MB, Mulligan K, Barbour JD, Schmidt D, Grant RM, Halvorsen RA, Schambelan M, McCune JM. Increased thymic mass and circulating naive CD4 T cells in HIV-1-infected adults treated with growth hormone. AIDS. 2002 May 24;16(8):1103-11. doi: 10.1097/00002030-200205240-00003.
PubMed 12004268Murphy WJ, Durum SK, Longo DL. Role of neuroendocrine hormones in murine T cell development. Growth hormone exerts thymopoietic effects in vivo. J Immunol. 1992 Dec 15;149(12):3851-7.
PubMed 1460277
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone Administration and the Human Immune System
- ClinicalTrials.gov ID
- NCT00663611
- Acronym / sponsor ID
- 999907260
- Conditions
- Healthy Volunteers
- Keywords
- Immune Function, Metabolism, Pulsatile Growth Hormone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 19 Oct 2006
- Primary completion
- 6 Oct 2014 (actual)
- Study completion
- 6 Oct 2014 (actual)
- First posted
- 22 Apr 2008 (estimated)
- 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.
Background:
- In elderly individuals, an age-associated decline in the immune system s ability to function is believed to contribute to increased incidence of infection, autoimmune disorders, and cancer. This decline in immune system function may be related to the decline in the body s production of growth hormone, which helps regulate human development and may contribute to the health of the immune system. Researchers are interested in studying whether growth hormone, given as an infusion over time, can improve the function of the immune system and other body systems associated with good health.
Objectives:
- To study the effects of growth hormone administration on the immune systems of healthy men.
Eligibility:
- Healthy men between 25 and 50 years of age.
Design:
- This protocol will involve three separate studies: Study I, Study IB, and Study II. Participants in Study I and Study IB may participate in Study II as directed by the researchers.
- Participants will be screened with a full medical history and physical examination, and will provide blood, urine, and stool samples; have a glucose tolerance test; and have other tests as required by the researchers.
- Participants will have an infusion pump with a small catheter inserted beneath the skin to administer the study chemicals (either growth hormone or placebo).
- Study I and Study IB participants will receive pulses of growth hormone through the infusion pump at regular intervals to monitor the body s response to the hormone. Study IB participants will receive a higher dose of growth hormone than Study I participants.
- Throughout the study period, all participants will have frequent blood and urine tests, as well as tests of glucose tolerance and metabolism, imaging studies, and other tests as required by the researchers.
- Study II participants will be divided into two groups. The first group will receive pulses of either growth hormone or placebo infusion at intervals throughout the day for 4 weeks, followed by an 8-week period without infusions. The second group will receive conventional once-a-day infusion of growth hormone or placebo for 4 weeks, followed by an 8-week period without infusions.
- Throughout the study period, all participants will have frequent blood and urine tests, as well as tests of glucose tolerance and metabolism, imaging studies, and other tests as required by the researchers.
Detailed description
Objectives and Specific Aims:
We plan to investigate whether growth hormone, administered in a physiological or pulsatile fashion, can elicit relevant changes in the human immune system while at the same time associated with no change or even an improvement in the metabolic profiles such as insulin sensitivity.
Experimental Design and Methods:
Thirty-eight healthy men, age 25-50, will be recruited for this study. There are three parts to this study: Study I, Study IB and Study II. Study I and IB each involve six subjects and are designed to test the hypothesis that pulsatile subcutaneous infusion of GH via a subcutaneous infusion pump yields a reasonable pulsatile GH pattern. The dose of GH used in Study IB is three-fold higher than in Study I. Study I and IB are done first before proceeding to Study II.
Study II is a randomized, double-blinded, placebo-controlled 12-week study involving 26 subjects divided into 2 groups: Group A and Group B. Group A involves 13 subjects receiving pulsatile GH or placebo infusion for 4 weeks with 8-week washout after intervention. Group B involves 13 subjects receiving conventional once a day subcutaneous infusion of GH or placebo for 4 weeks with 8-week washout after intervention.
Medical Relevance and Expected Outcome:
This study ascertains the significance of the effect of pulsatile growth hormone administration on the human immune system and metabolic profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study I and IB | Experimental | Drug: NorditropinEach involve six subjects and are designed to test the hypothesis that pulsatile subcutaneous infusion of GH via a subcutaneous infusion pump will yield a reasonable pulsatile GH pattern. The dose of GH used in Study IB will be three-fold higher than that in Study I. Study I and IB will be done first before proceeding to Study II |
| Study II | Experimental | Drug: Norditropin, Drug: PlaceboIs a randomized, double-blinded, placebo-controlled 12 week study involving 26 subjects divided into 2 groups: Group A and Group B. Group A will involve 13 subjects receiving pulsatile GH or placebo infusion for 4 weeks with 8 week washout after intervention. Group B will involve 13 subjects receiving conventional once a day subcutaneous infusion of GH or placebo for 4 weeks with 8 week washout after intervention. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
Key exclusion criteria (17 listed)
- Women
- FPG >= 100 mg/dL or 2-hour OGTT >= 140 mg/dL
- Abnormal electrocardiogram (EKG) suggesting possible underlying cardiac conditions that, in the opinion of the investigator(s), may cause participation of the subject in the study unsafe
- Positive stool guaiac
- Evidence of illicit drug use
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 |
|---|---|---|
| NorditropinNorditropin (somatropin, rDNA origin) is a polypeptide hormone of recombinant DNA origin. The amino acid sequence of the product is identical to that of the human growth hormone of pituitary origin. | Drug | Study I and IB, Study II |
| Placebo0.9% normal saline | Drug | Study II |
Primary outcome
GH administration may elicit clinical significant and relevant changes in the human immune system
Time frame: 4 weeks
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 5 Nov 2026.
- Background: PubMed 7725388Bar-Dayan Y, Small M. Effect of bovine growth hormone administration on the pattern of thymic involution in mice. Thymus. 1994;23(2):95-101.
- Background: PubMed 12004268Napolitano LA, Lo JC, Gotway MB, Mulligan K, Barbour JD, Schmidt D, Grant RM, Halvorsen RA, Schambelan M, McCune JM. Increased thymic mass and circulating naive CD4 T cells in HIV-1-infected adults treated with growth hormone. AIDS. 2002 May 24;16(8):1103-11. doi: 10.1097/00002030-200205240-00003.
- Background: PubMed 1460277Murphy WJ, Durum SK, Longo DL. Role of neuroendocrine hormones in murine T cell development. Growth hormone exerts thymopoietic effects in vivo. J Immunol. 1992 Dec 15;149(12):3851-7.
- Individual participant dataSharing planned: Undecided. The NIA IRP is discussing the plan to make IPD available. A final decision has not been made.
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Screening Protocol
Pain
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.
Chee W Chia, M.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Norditropin in people with Healthy Volunteers, run by National Institute on Aging (NIA) 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 15 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 5 Nov 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
GH administration may elicit clinical significant and relevant changes in the human immune system (time frame: 4 weeks). 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 NCT00663611, which also lists 3 linked publications.
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 5 Nov 2026.