Effects of Growth Hormone on the Nitric Oxide Pathway

NCT00470002 | Completed Phase 1

• 3 other identifiers: MES 03069VP2-3900-4021576IRB#3444
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

growth hormone; nitric oxide; nitrate; cyclic guanosine monophosphate; insulin-like growth factor-1; asymmetric dimethylarginine; blood pressure; endothelial progenitor cells

Outcome Measures

Primary Outcomes (1)

• Urinary nitrate excretion

  10 days

Secondary Outcomes (1)

• Insulin-like growth factor-1 in serum

  10 days

Interventions

Somatropin DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hannover Medical School: lead
• Pharmacia: collaborator

Study Sites (1)

Institute of Clinical Pharmacology, Hannover Medical School

Hanover, Lower Saxony, 30623, Germany

Location

Related Publications (2)

• Boger RH, Skamira C, Bode-Boger SM, Brabant G, von zur Muhlen A, Frolich JC. Nitric oxide may mediate the hemodynamic effects of recombinant growth hormone in patients with acquired growth hormone deficiency. A double-blind, placebo-controlled study. J Clin Invest. 1996 Dec 15;98(12):2706-13. doi: 10.1172/JCI119095.

  PMID: 8981915 BACKGROUND

• Tsukahara H, Gordienko DV, Tonshoff B, Gelato MC, Goligorsky MS. Direct demonstration of insulin-like growth factor-I-induced nitric oxide production by endothelial cells. Kidney Int. 1994 Feb;45(2):598-604. doi: 10.1038/ki.1994.78.

  PMID: 7513035 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dirk O Stichtenoth, MD

  Institute of Clinical Pharmacology, Hannover Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2007
• First Posted: May 7, 2007
• Study Start: May 1, 2004
• Study Completion: January 1, 2005
• Last Updated: May 7, 2007

Record last verified: 2007-05

Locations

DE (1)