NCT00711061

Brief Summary

The purpose of this study is to compare the cardiovascular risks of growth hormone deficient young adult males who have completed growth hormone therapy to healthy young adult males.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 10, 2009

Status Verified

February 1, 2009

Enrollment Period

8 months

First QC Date

July 3, 2008

Last Update Submit

February 9, 2009

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

  • Compare carotid artery intima medial thickness

    During study visit

Secondary Outcomes (1)

  • Compare metabolic parameters and body composition measurements

    During study visit

Study Arms (2)

1

18-25 year old males, growth hormone deficient, who completed growth hormone treatment 3-5 years prior to enrollment in study

2

18-25 year old males, healthy, never treated with growth hormones.

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Endocrine clinic and community sample

You may qualify if:

  • Males, 18-25 years old
  • Completed growth hormone therapy approximately 3-5 years prior to study enrollment
  • History of multiple pituitary hormone deficiencies or growth hormone stimulation test \<7 at initiation of growth hormone therapy
  • Males, 18-25 years old
  • No confirmed endocrine diagnosis including Diabetes and thyroid disorders
  • BMI - z-score within 2 SD of mean

You may not qualify if:

  • Known risk factors for cardiovascular disease (eg tobacco use, hypertension, diabetes)
  • Family history of early cardiovascular disease (myocardial infarction or stroke \<55years of age) in first degree family members
  • Any implanted device
  • Medication known to interfere with glucose or lipid metabolism or to influence blood pressure
  • Chronic organ illness (eg severe asthma, hepatic or nephritic conditions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

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

Study Officials

  • Carol Huseman, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 8, 2008

Study Start

June 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 10, 2009

Record last verified: 2009-02

Locations

US(1)