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

Children's Mercy Hospital Kansas City

Status: Completed

Conditions: Growth Hormone Deficiency

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00711061

07-07-119E

Details and patient eligibility

About

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.

Full 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

Enrollment: 24 patients

Sex: Male

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

24 participants in 2 patient groups

1

Description:

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

2

Description:

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