Turner SyndromeNCT02160717
Risk of Diabetes in Young Turner Syndrome Patients
An observational study of Turner Syndrome, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Turner Syndrome is a common genetic disorder. Seventy percent of adults with Turner Syndrome have abnormalities in glucose metabolism which can lead to diabetes. The current screening guidelines for diabetes in Turner Syndrome are not specific and involve a fasting blood sugar once a year. Read more about this study
- Who is it for?
- Ages 6 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Turner Syndrome
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jun 2017
- 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 6 to 22 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Primary Care Clinic Turner Syndrome Center of Cincinnati Community Sample
Who may be able to join
- Turner Syndrome confirmed by chromosomal testing
- On standard therapy (growth hormone and or estrogen)
- Healthy
Who cannot join
- Type 1 or Type 2 diabetes
- Polycystic Ovarian Syndrome
- Pregnancy
- On any medications that alter blood sugar
- Healthy Female Controls:
- Type 1 or Type 2 diabetes
Show all 9Show fewer
- Polycystic Ovarian Syndrome
- Pregnancy
- On any medications that alter blood sugar
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Medical Center, Cincinnati
Cincinnati, Ohio, 45229
About this study
Official title: Beta-Cell Function in Young Turner Syndrome Patients
Turner Syndrome is a common genetic disorder. Seventy percent of adults with Turner Syndrome have abnormalities in glucose metabolism which can lead to diabetes. The current screening guidelines for diabetes in Turner Syndrome are not specific and involve a fasting blood sugar once a year. The objective of this study is to determine if there are abnormalities in glucose metabolism and pancreatic function in young girls with Turner Syndrome. The study hypothesis is that pancreatic dysfunction (specifically of the beta cells that make insulin) is more prevalent in girls with Turner Syndrome compared to healthy controls.
Read the detailed description
The study will be conducted at Children's Hospital Medical Center, Cincinnati. The study will require 1 visit to the hospital where the subject will have an oral glucose tolerance test and a physical exam
- Conditions
- Turner Syndrome
- Keywords
- Turner Syndrome, Diabetes
- Medical subject headings
- Turner Syndrome, Diabetes Mellitus
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 |
|---|---|---|
| Turner Syndrome | Female with Turner Syndrome | |
| Healthy Controls | Healthy Female |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-Cell Function measured as Disposition Index
Disposition index will be calculated based on the results of the oral glucose tolerance test using minimal modeling (computer program)
Measured: 1 day at screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Turner SyndromeStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Nicole Sheanon, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160717
- Sponsor's protocol ID
- CCHMC-906
- Other IDs
- UL1TR000077
- Status last verified
- Aug 2017
- First submitted
- 4 Jun 2014
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-Cell Function in Young Turner Syndrome Patients
- ClinicalTrials.gov ID
- NCT02160717
- Acronym / sponsor ID
- CCHMC-906
- Conditions
- Turner Syndrome
- Keywords
- Turner Syndrome, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- May 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 11 Jun 2014 (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.
Turner Syndrome is a common genetic disorder. Seventy percent of adults with Turner Syndrome have abnormalities in glucose metabolism which can lead to diabetes. The current screening guidelines for diabetes in Turner Syndrome are not specific and involve a fasting blood sugar once a year. The objective of this study is to determine if there are abnormalities in glucose metabolism and pancreatic function in young girls with Turner Syndrome. The study hypothesis is that pancreatic dysfunction (specifically of the beta cells that make insulin) is more prevalent in girls with Turner Syndrome compared to healthy controls.
Detailed description
The study will be conducted at Children's Hospital Medical Center, Cincinnati. The study will require 1 visit to the hospital where the subject will have an oral glucose tolerance test and a physical exam
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Turner Syndrome | – | –Female with Turner Syndrome |
| Healthy Controls | – | –Healthy Female |
Who may qualify
- Ages
- 6 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Primary Care Clinic Turner Syndrome Center of Cincinnati Community Sample
Key inclusion criteria (3 listed)
- Turner Syndrome confirmed by chromosomal testing
- On standard therapy (growth hormone and or estrogen)
- Healthy
Key exclusion criteria (9 listed)
- Type 1 or Type 2 diabetes
- Polycystic Ovarian Syndrome
- Pregnancy
- On any medications that alter blood sugar
- Type 1 or Type 2 diabetes
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
Beta-Cell Function measured as Disposition Index
Time frame: 1 day at screening
Disposition index will be calculated based on the results of the oral glucose tolerance test using minimal modeling (computer program)
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 23 Aug 2017.
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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.
Nicole Sheanon, MD principal investigator
Children's Hospital Medical Center, Cincinnati
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 Turner Syndrome, run by Children's Hospital Medical Center, Cincinnati 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 3 inclusion and 9 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 23 Aug 2017. 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?
Beta-Cell Function measured as Disposition Index (time frame: 1 day at screening). 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 23 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.