Status:
COMPLETED
Effects of Growth Hormone on the Nitric Oxide Pathway
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Pharmacia
Conditions:
Cardiovascular Disease
Eligibility:
MALE
50+ years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine whether the treatment with growth hormone has an influence on the nitric oxide pathway in healthy males.
Detailed Description
Nitric oxide (NO) is a potent endogenous vasodilator and has shown to inhibit key processes of atherosclerosis like monocyte adhesion, platelet aggregation, and vascular smooth muscle cell proliferati...
Eligibility Criteria
Inclusion
- Healthy male subjects without recent severe diseases
- Age 50 yrs or older
- Body mass index at or below 30 kg/m2
- Insulin-like growth factor-1 level below 200 ng/ml
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
- Subjects that are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Exclusion
- History of any severe hepatic, renal, cardiac, endocrine, metabolic, or malignant diseases
- Requirement for medical drug treatment
- Growth hormone treatment during the last 12 months
- Drug dependence, alcohol or nicotine abuse
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00470002
Start Date
May 1 2004
End Date
January 1 2005
Last Update
May 7 2007
Active Locations (1)
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1
Institute of Clinical Pharmacology, Hannover Medical School
Hanover, Lower Saxony, Germany, 30623