Growth Hormone Administration and the Human Immune System - I

Aging Clinical Trial

Official title:

Growth Hormone Administration and the Human Immune System - I

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00663676
• Other study ID #: AG0100
• Status: Active, not recruiting
• Phase: Phase 0
• First received: April 21, 2008
• Last updated: September 17, 2013
• Start date: September 2007
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study is designed to test the hypothesis that pulsatile (pulse-like) subcutaneous (under the skin) infusion of growth hormone (GH) via a pump will yield a reasonable pulsatile GH pattern.

Description:

Growth hormone (GH) may enhance the way the human immune system responds. The human body secretes GH in a pulse-like fashion throughout the day. In this study human recombinant GH will be given using a continuous infusion pump to imitate how GH is naturally secreted.

This study, Study I, involves six subjects and is designed to test the hypothesis that pulsatile subcutaneous infusion of GH via a pump will yield a reasonable pulsatile GH pattern. Study I involves one inpatient visit. Procedures during this study include blood draws, MRI, and insulin clamp procedures.

Study I will be followed by Study Ib, with the same six participants. Study Ib will test the hypothesis that pulsatile subcutaneous infusion of GH via a pump will yield a reasonable pulsatile GH pattern. GH will be administered at three times the dose that was used in Study I. Study Ib involves one screening visit and one inpatient overnight visit. No MRI or insulin clamp procedure will be performed.

This study will be followed by Study II, which is the main study and will examine the effects of GH via subcutaneous infusion pump in a pulsatile fashion compared with once-a-day bolus for 4 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy men only

• Screening laboratory evaluations with no clinically significant abnormal results

• fasting comprehensive metabolic panel

• complete blood count with differential and platelets

• 75-gram oral glucose tolerance test (OGTT)

• fasting plasma glucose (FPG) less than 100 mg/dL

• 2-hr OGTT less than 140 mg/dL

• Insulin-like growth factor-I (IGF-I)

• thyroid function test (TSH, free T3, free T4)

• fasting lipid profile

• BMI less than 30

• Have NOT participated in another clinical trial involving any pharmacologic agents within the past 60 days

• Able to complete an informed consent

• Agree to not participate in other clinical trials within the study period

Exclusion Criteria:

• Women

• FPG 100 mg/dL or higher, or 2-hour OGTT 140 mg/dL or higher

• Abnormal Electrocardiogram (EKG)

• Positive stool guaiac

• Evidence of illicit drug use

• History of smoking any tobacco products within one year prior to screening

• Alcohol intake greater than 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 in the study unsafe

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Immune System and Related Disorders

Intervention

Drug:
• human recombinant growth hormone (Growth Hormone)
administered via a subcutaneous infusion pump for 24 hours

Locations

Country	Name	City	State
United States	National Institute on Aging Clinical Research Unit	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Murphy WJ, Durum SK, Longo DL. Differential effects of growth hormone and prolactin on murine T cell development and function. J Exp Med. 1993 Jul 1;178(1):231-6. — View Citation

Murphy 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. — View Citation

Steinmann GG, Klaus B, Müller-Hermelink HK. The involution of the ageing human thymic epithelium is independent of puberty. A morphometric study. Scand J Immunol. 1985 Nov;22(5):563-75. — View Citation

Steinmann GG. Changes in the human thymus during aging. Curr Top Pathol. 1986;75:43-88. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma GH levels		36 hours	No
Secondary	Metabolic profile		36 hours	No