Growth Hormone DeficiencyNCT00711061
Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy
An observational study of Growth Hormone Deficiency, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Deficiency
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Endocrine clinic and community sample
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Childrens Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
About this study
Official title: 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.
Read the 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:
- Carotid artery imaging
- Metabolic and cardiac parameters
- Body composition measurements
- Conditions
- Growth Hormone Deficiency
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Compare carotid artery intima medial thickness
Measured: During study visit
Secondary outcomes (1)
Compare metabolic parameters and body composition measurements
Measured: During study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Carol Huseman, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711061
- Sponsor's protocol ID
- 07-07-119E
- Status last verified
- Feb 2009
- First submitted
- 3 Jul 2008
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy.
- ClinicalTrials.gov ID
- NCT00711061
- Acronym / sponsor ID
- 07-07-119E
- Conditions
- Growth Hormone Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Carotid artery imaging
- Metabolic and cardiac parameters
- Body composition measurements
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Endocrine clinic and community sample
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare carotid artery intima medial thickness
Time frame: During study visit
1 secondary outcome
Compare metabolic parameters and body composition measurements
Time frame: During study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2009.
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Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
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Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Huseman, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare carotid artery intima medial thickness (time frame: During study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2009.