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

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.

Study Overview

• Status: Completed
• Conditions: Growth Hormone Deficiency

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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Childrens Mercy Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Endocrine clinic and community sample

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare carotid artery intima medial thickness	During study visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare metabolic parameters and body composition measurements	During study visit

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Carol Huseman, MD, Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: July 3, 2008
• First Submitted That Met QC Criteria: July 7, 2008
• First Posted (Estimate): July 8, 2008

Study Record Updates

• Last Update Posted (Estimate): February 10, 2009
• Last Update Submitted That Met QC Criteria: February 9, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: 07-07-119E