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Completed

NCT Number: NCT00711061

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

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.

Completed

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Key information

Age range

18 year–25 year

Sex eligibility

Male

Study type

Observational

Primary location

Childrens Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

About this study

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:

  • Carotid artery imaging
  • Metabolic and cardiac parameters
  • Body composition measurements

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Compare carotid artery intima medial thickness

    Time frame: During study visit

Secondary outcomes

  1. Compare metabolic parameters and body composition measurements

    Time frame: During study visit

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 8, 2008
Registry last updated
Feb 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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