Growth Hormone Administration and the Human Immune System - II - Tabular View

Tracking Information

First Received Date ^ICMJE

April 21, 2008

Last Updated Date

December 29, 2008

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Immune Response [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00663611 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Metabolic profile [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Growth Hormone Administration and the Human Immune System - II

Official Title ^ICMJE

Growth Hormone Administration and the Human Immune System - II

Brief Summary

This study will investigate whether growth hormone, administered in a physiological or pulsatile (pulse-like) fashion, can elicit relevant changes in the human immune system while at the same time causing either no change or even an improvement in the metabolic profiles such as insulin sensitivity.

Detailed 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 so that investigators can observe how the human body responds to this method versus daily injections. Specifically, investigators will look at any relevant changes in the human immune system, metabolic profile, and possible side effects.

GH will be administered via subcutaneous (below the skin) infusion pump in a pulsatile fashion compared with once-a-day bolus for 4 weeks. Participants will be wearing this infusion pump continuously for 4 weeks. This study involves two inpatient visits, two 1-day outpatient visits, and about 9-14 short outpatient visits over a 3 month period. Procedures during this study include blood draws, MRI, CT, DEXA scan, insulin clamp procedures, oral glucose tolerance tests, and urine tests

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Aging
Immune System

Intervention ^ICMJE

Drug: human recombinant growth hormone (Growth Hormone)
Drug: Placebo

Study Arms / Comparison Groups

Experimental: GH administered in a pulsatile fashion
Experimental: GH administered as once-a-day bolus
Placebo Comparator: Placebo administered in a pulsatile fashion
Placebo Comparator: Placebo administered as once-a-day bolus

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

30 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Charles Padgett, RN	410-350-7395	padgettca@nia.nih.gov
Contact: Clinical Research Recruitment Office	410-350-3941	NIAStudiesRecruitment@mail.nih.gov

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00663611

Responsible Party

Chee W. Chia, MD, NIH/NIA/CRB

Study ID Numbers ^ICMJE

AG0101

Study Sponsor ^ICMJE

National Institute on Aging (NIA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Chee W. Chia, MD

NIH/NIA/CRB

Information Provided By

National Institute on Aging (NIA)

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP