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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00711061
First received: July 3, 2008
Last updated: February 9, 2009
Last verified: February 2009
  Purpose

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.


Condition
Growth Hormone Deficiency

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy.

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Compare carotid artery intima medial thickness [ Time Frame: During study visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare metabolic parameters and body composition measurements [ Time Frame: During study visit ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
18-25 year old males, growth hormone deficient, who completed growth hormone treatment 3-5 years prior to enrollment in study
2
18-25 year old males, healthy, never treated with growth hormones.

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
  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Endocrine clinic and community sample

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711061

Locations
United States, Missouri
Childrens Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Genentech
Investigators
Principal Investigator: Carol Huseman, MD Children's Mercy Hospital Kansas City
  More Information

No publications provided

Responsible Party: Carol Huseman, MD, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00711061     History of Changes
Other Study ID Numbers: 07-07-119E
Study First Received: July 3, 2008
Last Updated: February 9, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014