Turner SyndromeNCT00419107
Beta Cell Function in Women With Turner Syndrome
An observational study of Turner Syndrome, run by University of Aarhus at 1 site in Denmark.
Trial summary
Diabetes is more frequent in women with Turner syndrome. The purpose of this study is to see, in what ways the glucose metabolism is different in this study population. The hypothesis is that women with Turner Syndrome have an impaired insulin production (beta cell function). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Turner Syndrome
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2004to Jan 2007
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 13 women with TS and 12 control women
Who may be able to join
- Turner syndrome
Who cannot join
- Diagnosed diabetes
- BMI>30
- Untreated cardiac or thyroid disease
- Cancer illness
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital
Aarhus, Aarhus C, 8000
About this study
Diabetes is more frequent in women with Turner syndrome. The purpose of this study is to see, in what ways the glucose metabolism is different in this study population. The hypothesis is that women with Turner Syndrome have an impaired insulin production (beta cell function).
- Conditions
- Turner Syndrome
- Medical subject headings
- Turner Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startNov 2004
- Study completionJan 2007
Why it stopped: Completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Turner SyndromeStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Jens Sandahl Christiansen, prof. dr.med, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419107
- Sponsor's protocol ID
- 20040108
- Status last verified
- Nov 2011
- First submitted
- 5 Jan 2007
- Last updated
- 8 Nov 2011
- Results posted
- No
Publications
Hjerrild BE, Holst JJ, Juhl CB, Christiansen JS, Schmitz O, Gravholt CH. Delayed beta-cell response and glucose intolerance in young women with Turner syndrome. BMC Endocr Disord. 2011 Mar 15;11:6. doi: 10.1186/1472-6823-11-6.
PubMed 21406078
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta Cell Function in Women With Turner Syndrome
- ClinicalTrials.gov ID
- NCT00419107
- Acronym / sponsor ID
- 20040108
- Conditions
- Turner Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2004
- Study completion
- Jan 2007 (actual)
- First posted
- 8 Jan 2007 (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.
Diabetes is more frequent in women with Turner syndrome. The purpose of this study is to see, in what ways the glucose metabolism is different in this study population. The hypothesis is that women with Turner Syndrome have an impaired insulin production (beta cell function).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 13 women with TS and 12 control women
Key inclusion criteria (1 listed)
- Turner syndrome
Key exclusion criteria (4 listed)
- Diagnosed diabetes
- BMI>30
- Untreated cardiac or thyroid disease
- Cancer illness
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
- Derived from this study: PubMed 21406078Hjerrild BE, Holst JJ, Juhl CB, Christiansen JS, Schmitz O, Gravholt CH. Delayed beta-cell response and glucose intolerance in young women with Turner syndrome. BMC Endocr Disord. 2011 Mar 15;11:6. doi: 10.1186/1472-6823-11-6.
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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.
Jens Sandahl Christiansen, prof. dr.med principal investigator
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 University of Aarhus at 1 site in Denmark.
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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Nov 2011. 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 Denmark. 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 was stopped early (reason given: Completed). Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00419107, 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 8 Nov 2011.