Growth Hormone Administration and the Human Immune System - II - Full Text View

Sponsor:	National Institute on Aging (NIA)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00663611

Purpose

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.

Condition	Intervention
Aging Immune System	Drug: human recombinant growth hormone (Growth Hormone) Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Growth Hormone Administration and the Human Immune System - II

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A1 GH administered in a pulsatile fashion	Drug: human recombinant growth hormone (Growth Hormone) 8 mcg/kg/day administered via a subcutaneous infusion pump for 4 weeks Other Name: human recombinant growth hormone
Experimental: B1 GH administered as once-a-day bolus	Drug: human recombinant growth hormone (Growth Hormone) 8 mcg/kg/day administered via a subcutaneous infusion pump for 4 weeks Other Name: human recombinant growth hormone
Placebo Comparator: A2 Placebo administered in a pulsatile fashion	Drug: Placebo Administered via a subcutaneous infusion pump for 4 weeks
Placebo Comparator: B2 Placebo administered as once-a-day bolus	Drug: Placebo Administered via a subcutaneous infusion pump for 4 weeks

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

Eligibility

Ages Eligible for Study:	30 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663611

Contacts

Contact: Denise melvin, RN	410-350-3924	Melvinde@mail.nia.nih
Contact: Clinical Research Recruitment Office	410-350-3941	NIAStudiesRecruitment@mail.nih.gov

Locations

United States, Maryland
NIA Clinical Research Unit located at Harbor Hospital	Recruiting
Baltimore, Maryland, United States, 21225
Contact: Denise melvin, RN 410-350-3924 Melvinde@mail.nia.nih
Principal Investigator: Chee Chia, MD

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Chee W. Chia, MD

NIH/NIA/CRB

More Information

Publications:

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.

Steinmann GG. Changes in the human thymus during aging. Curr Top Pathol. 1986;75:43-88. Review. No abstract available.

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.

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.

Responsible Party:	Chee W. Chia, MD, NIH/NIA/CRB
ClinicalTrials.gov Identifier:	NCT00663611 History of Changes
Other Study ID Numbers:	AG0101
Study First Received:	April 21, 2008
Last Updated:	October 15, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Thymus
glucose
metabolism
pulsatile
insulin

Additional relevant MeSH terms:

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012