Status:
COMPLETED
Growth Hormone Administration and the Human Immune System
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Healthy Volunteers
Eligibility:
MALE
25-50 years
Phase:
PHASE1
Brief 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 ca...
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 ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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)
- 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
- EXCLUSION CRITERIA:
- 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
- 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
Exclusion
Key Trial Info
Start Date :
October 19 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00663611
Start Date
October 19 2006
End Date
October 6 2014
Last Update
January 8 2026
Active Locations (1)
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1
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224