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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00711061

Enrollment

Registered

2008-07-08

Start date

2008-06-30

Completion date

2009-02-28

Last updated

2009-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 25 Years

Healthy volunteers

Yes

Inclusion criteria

Growth Hormone Deficient 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 Healthy Control Inclusion Criteria: * 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)

Design outcomes

Primary

Measure	Time frame
Compare carotid artery intima medial thickness	During study visit

Secondary

Measure	Time frame
Compare metabolic parameters and body composition measurements	During study visit

Countries

United States

Outcome results