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

Completed

• Conditions: Growth Hormone Deficiency

• Registration Number: NCT00711061
• Lead Sponsor: Children's Mercy Hospital Kansas City

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

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-07
• Study First Posted: 2008-07-08
• Status Verified: 2009-02
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-09
• Last Update Posted: 2009-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare carotid artery intima medial thickness	During study visit

Secondary Outcome Measures

Name	Time	Method
Compare metabolic parameters and body composition measurements	During study visit

Trial Locations

Locations (1)

Childrens Mercy Hospitals and Clinics; 🇺🇸 Kansas City, Missouri, United States