Idiopathic Short StatureNCT01070173
Ghrelin Levels in Children With Poor Growth
An observational study of Idiopathic Short Stature and Failure to Thrive, run by Tripler Army Medical Center at 1 site in United States.
Trial summary
The investigators hypothesize that low serum ghrelin levels may characterize a group of patients with poor weight gain and/or linear growth who do not have any other identified cause for growth failure. Read more about this study
- Who is it for?
- Ages 3 months to 21 years
- Conditions the study is for
- Idiopathic Short Stature, Failure to Thrive
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Sep 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Twenty-five (25) patients seen for evaluation of short stature in the pediatric endocrinology clinic will have serum ghrelin levels measured in addition to their usual routine bloods tests. Twenty-five (25) patients will be selected from patients who present with chronic gastrointestinal symptoms (symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms) and who have poor growth. The remaining 25 will be selected from patients with chronic gastrointestinal symptoms (symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms) who have normal growth.
Who may be able to join
- To be included in the short stature group, subjects must have had short stature, defined height less than -2 SD for gender and age or an abnormal growth velocity for gender and age).
- To be included in the failure-to-thrive group, subjects must have had poor weight gain, defined as weight less than -2 SD for gender and age or an abnormal weight velocity for gender and age.
- Patients in both groups will be evaluated for the presence of chronic gastrointestinal symptoms, defined as symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms. Patients who were affected in both weight and height will be stratified by which measurement was more severely affected, with poor weight gain being the primary problem in the "failure-to-thrive" grouping (Group 2) and "poor linear growth" being the primary problem in the short stature group (Group 1).
- Patients who have had chronic gastrointestinal symptoms, defined as symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms, but normal stature and growth, will be analyzed separately (Group 3).
Who cannot join
- Must not have a known diagnosis as an etiology for growth failure or GI symptoms prior to presentation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tripler Army Medical Center/Dept of Pediatrics
Tripler AMC, Hawaii, 96859
About this study
Official title: Ghrelin Levels in Children With Gastrointestinal Symptoms and/or Poor Growth
The investigators hypothesize that low serum ghrelin levels may characterize a group of patients with poor weight gain and/or linear growth who do not have any other identified cause for growth failure. These patients may present with a variety of complaints and are often evaluated by both pediatric endocrinologists and pediatric gastroenterologists. The investigators hypothesize that ghrelin has a physiologically important role in linear growth and that chronic diseases of the gastrointestinal system, such as H. Pylori infection or celiac disease, may alter serum ghrelin levels in children. Low ghrelin levels may be a factor leading to poor growth, potentially by altering growth hormone secretion and/or by decreasing appetite. By measuring ghrelin levels in children with short stature and in children with gastrointestinal disease, the investigators will further elucidate the possible physiologic role of ghrelin in childhood growth and how it may be altered in conditions causing short stature and in certain gastrointestinal diseases.
- Conditions
- Idiopathic Short Stature, Failure to Thrive
- Keywords
- Ghrelin, short stature, failure to thrive
- Medical subject headings
- Failure to Thrive, Dwarfism
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 |
|---|---|---|
| Short Stature | Poor linear growth | |
| Poor Weight Gain (Failure-To-Thrive) | Poor Weight Gain | |
| Isolated Gastrointestinal Symptoms | No growth symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Ghrelin Level
Measured: Will be measured with baseline screening labs at enrollment.
Acylated Ghrelin Level
Measured: Will be measured with baseline screening labs at enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startJan 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Short StatureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tripler Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jordan Pinsker, Tripler Army Medical Center
- Investigators
- Jordan Pinsker, MD, Principal investigator, Tripler Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070173
- Sponsor's protocol ID
- 5H08
- Status last verified
- Jan 2013
- First submitted
- 12 Feb 2010
- Last updated
- 18 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pinsker JE, Ondrasik D, Chan D, Fredericks GJ, Tabisola-Nuesca E, Fernandez-Aponte M, Focht DR, Poth M. Total and acylated ghrelin levels in children with poor growth. Pediatr Res. 2011 Jun;69(6):517-21. doi: 10.1203/PDR.0b013e3182181b2c.
PubMed 21386753
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghrelin Levels in Children With Gastrointestinal Symptoms and/or Poor Growth
- ClinicalTrials.gov ID
- NCT01070173
- Acronym / sponsor ID
- 5H08
- Conditions
- Idiopathic Short Stature, Failure to Thrive
- Keywords
- Ghrelin, short stature, failure to thrive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tripler Army Medical CenterUS federal agency
- Study start
- Jan 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Posted 18 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that low serum ghrelin levels may characterize a group of patients with poor weight gain and/or linear growth who do not have any other identified cause for growth failure. These patients may present with a variety of complaints and are often evaluated by both pediatric endocrinologists and pediatric gastroenterologists. The investigators hypothesize that ghrelin has a physiologically important role in linear growth and that chronic diseases of the gastrointestinal system, such as H. Pylori infection or celiac disease, may alter serum ghrelin levels in children. Low ghrelin levels may be a factor leading to poor growth, potentially by altering growth hormone secretion and/or by decreasing appetite. By measuring ghrelin levels in children with short stature and in children with gastrointestinal disease, the investigators will further elucidate the possible physiologic role of ghrelin in childhood growth and how it may be altered in conditions causing short stature and in certain gastrointestinal diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short Stature | – | –Poor linear growth |
| Poor Weight Gain (Failure-To-Thrive) | – | –Poor Weight Gain |
| Isolated Gastrointestinal Symptoms | – | –No growth symptoms |
Who may qualify
- Ages
- 3 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Twenty-five (25) patients seen for evaluation of short stature in the pediatric endocrinology clinic will have serum ghrelin levels measured in addition to their usual routine bloods tests. Twenty-five (25) patients will be selected from patients who present with chronic gastrointestinal symptoms (symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms) and who have poor growth. The remaining 25 will be selected from patients with chronic gastrointestinal symptoms (symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms) who have normal growth.
Key inclusion criteria (4 listed)
- To be included in the short stature group, subjects must have had short stature, defined height less than -2 SD for gender and age or an abnormal growth velocity for gender and age).
- To be included in the failure-to-thrive group, subjects must have had poor weight gain, defined as weight less than -2 SD for gender and age or an abnormal weight velocity for gender and age.
- Patients in both groups will be evaluated for the presence of chronic gastrointestinal symptoms, defined as symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms. Patients who were affected in both weight and height will be stratified by which measurement was more severely affected, with poor weight gain being the primary problem in the "failure-to-thrive" grouping (Group 2) and "poor linear growth" being the primary problem in the short stature group (Group 1).
- Patients who have had chronic gastrointestinal symptoms, defined as symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms, but normal stature and growth, will be analyzed separately (Group 3).
Key exclusion criteria (1 listed)
- Must not have a known diagnosis as an etiology for growth failure or GI symptoms prior to presentation.
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
Total Ghrelin Level
Time frame: Will be measured with baseline screening labs at enrollment.
Acylated Ghrelin Level
Time frame: Will be measured with baseline screening labs at enrollment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21386753Pinsker JE, Ondrasik D, Chan D, Fredericks GJ, Tabisola-Nuesca E, Fernandez-Aponte M, Focht DR, Poth M. Total and acylated ghrelin levels in children with poor growth. Pediatr Res. 2011 Jun;69(6):517-21. doi: 10.1203/PDR.0b013e3182181b2c.
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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.
Jordan Pinsker, MD principal investigator
Tripler Army Medical Center
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 Idiopathic Short Stature and Failure to Thrive, run by Tripler Army Medical Center 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 4 inclusion and 1 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 18 Feb 2013. 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?
Yes. Results are posted in the registry (first posted 18 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Ghrelin Level (time frame: Will be measured with baseline screening labs at enrollment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01070173, which also lists 1 linked publication.
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 18 Feb 2013.