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Growth Hormone Administration and the Human Immune System


Phase 1
25 Years
50 Years
Open (Enrolling)
Male
Age-Associated Decline, Aging Immune System

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Trial Information

Growth Hormone Administration and the Human Immune System


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 will yield a reasonable pulsatile GH pattern. The dose of GH used
in Study IB will be three-fold higher that that in Study I. Study I and IB will be 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 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.

Medical Relevance and Expected Outcome:

This study will ascertain the significance of the effect of pulsatile growth hormone
administration on the human immune system and metabolic profile.

Inclusion Criteria


- INCLUSION CRITERIA:

1. Healthy men only

2. Age 25-50

3. Screening laboratory evaluations with no clinically significant abnormal results
(minor deviations from normal lab results will be at the discretion of the
principal investigator):

1. fasting comprehensive metabolic panel

2. complete blood count with differential and platelets

3. 75-gram oral glucose tolerance test (OGTT)

- fasting plasma glucose (FPG) < 100 mg/dL

- 2-hr OGTT < 140 mg/dL

4. Insulin-like growth factor-I (IGF-I)

5. thyroid function test (TSH, free T3, free T4)

6. fasting lipid profile

4. BMI < 30

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

6. Able to complete an inform consent

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

EXCLUSION CRITERIA:

1. Women

2. FPG 100 mg/dL or 2-hour OGTT 140 mg/dL

3. 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

4. Positive stool guaiac

5. Evidence of illicit drug use

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

7. Alcohol intake > 30 grams (drink more than 2 beers per day OR equivalent amount of
alcohol)

8. History of Human Immunodeficiency Virus (HIV) infection

9. History of active or chronic Hepatitis B and/or C infection

10. History of malignancy

11. History of coronary disease

12. History of seizures or other neurologic diseases

13. History of liver or renal diseases

14. History of gastrointestinal or endocrine disorders

15. History of glucocorticoid use (over one month) or other immunosuppressive agents
(any)

16. unable to undergo a magnetic resonance imaging (MRI) procedure

17. Any medical history that, in the opinion of the investigator(s), will make
participation of the subject in the study unsafe

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

GH administration may elicit clinical significant and relevant changes in the human immune system

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Chee W Chia, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute on Aging (NIA)

Authority:

United States: Federal Government

Study ID:

999907260

NCT ID:

NCT00663611

Start Date:

October 2006

Completion Date:

December 2013

Related Keywords:

  • Age-Associated Decline
  • Aging Immune System
  • Thymus
  • Glucose
  • Metabolism
  • Pulsatile
  • Insulin

Name

Location
National Institute of Aging, Clinical Research Unit Baltimore, Maryland  21224