NCT00397319

Brief Summary

To evaluate specific markers of cardiovascular risk before and after growth hormone replacement therapy in a population of growth hormone deficient adults, as compared to an age, gender, and BMI-matched healthy population.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 3, 2007

Status Verified

July 1, 2007

First QC Date

November 8, 2006

Last Update Submit

July 2, 2007

Conditions

Growth Hormone Deficiency

Keywords

Growth HormoneCardiovascular System

Interventions

Growth HormoneDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult between the ages of 18 and 65
  • Documented Growth Hormone Deficiency as defined by a peak Growth Hormone during a GHRH-Arginine Stimulation test not exceeding 9.5 ng/ml

You may not qualify if:

  • Personal history of cardiovascular disease (previous myocardial infarction or known coronary artery disease) or diagnosis of heart disease between study visits.
  • Personal history of diabetes mellitus or development of diabetes between study visits.
  • Initiation of an anti-cholesterol medication or anti-hypertensive between baseline and follow-up study visit.
  • Initiation of regular tobacco use between baseline and follow-up study visit.
  • Pregnancy or nursing
  • Current daily use of any drug known to affect the fibrinolytic system: Aspirin, Aggrenox, Plavix, Persantine, Ticlid, Pletal, Trental, Lovenox, Coumadin, Agrylin, and Hydroxyurea.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Devin JK, Blevins LS Jr, Verity DK, Chen Q, Bloodworth JR Jr, Covington J, Vaughan DE. Markedly impaired fibrinolytic balance contributes to cardiovascular risk in adults with growth hormone deficiency. J Clin Endocrinol Metab. 2007 Sep;92(9):3633-9. doi: 10.1210/jc.2007-0609. Epub 2007 Jun 19.

    PMID: 17579195DERIVED

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Doug Vaughan, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2006

First Posted

November 9, 2006

Study Start

August 1, 2005

Study Completion

December 1, 2006

Last Updated

July 3, 2007

Record last verified: 2007-07

Locations

US(1)