Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy

NCT ID: NCT00711061

Last Updated: 2009-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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Adults with growth hormone deficiency are at risk for cardiovascular disease. What age this begins is not known.

The objectives of this study are to compare the following measurements between growth hormone deficient young males 3-7 years post completion of growth hormone treatment and age related healthy controls:

1. Carotid artery imaging
2. Metabolic and cardiac parameters
3. Body composition measurements

Conditions

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Growth Hormone Deficiency

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

No interventions assigned to this group

2

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Children's Mercy Hospital

Principal Investigators

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Carol Huseman, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

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Childrens Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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07-07-119E

Identifier Type: -

Identifier Source: org_study_id

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