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

Growth Hormone Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711061
• Other study ID #: 07-07-119E
• Status: Completed
• Phase: N/A
• First received: July 3, 2008
• Last updated: February 9, 2009
• Start date: June 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency

Locations

Country	Name	City	State
United States	Childrens Mercy Hospitals and Clinics	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare carotid artery intima medial thickness		During study visit	No
Secondary	Compare metabolic parameters and body composition measurements		During study visit	No