Turner SyndromeNCT03181230
Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome
An observational study of Turner Syndrome and Turner Syndrome Mosaicism, 45, X/46, XX or XY, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about how the energy system works in girls with Turner syndrome. This is important to know so that the investigators understand how Turner syndrome relates to diseases such as diabetes, extra weight gain, heart disease and liver disease, and how this impacts day to day life. Read more about this study
- Who is it for?
- Ages 12 to 21 years, women only
- Conditions the study is for
- Turner Syndrome, Turner Syndrome Mosaicism, 45, X/46, XX or XY, Turner Syndrome Mosaicism 46,X,I(X)(Q10)/45,X
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2017to 31 Dec 2018
- 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 12 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Investigators will enroll adolescent and young adult females with Turner syndrome who will complete all study procedures. One parent will also be enrolled (either mother or father) to complete questionnaires about the daughter.
Who may be able to join
- Female
- Age 12-21 years
- 45,XO karyotype in >50% of cells tested with a diagnosis of Turner syndrome (TS)
- Tanner stage 2-5 for breast development
Who cannot join
- Growth hormone treatment within the past 3 months
- Diagnosis of type 1 or type 2 diabetes
- Untreated hypertension with blood pressure > 99%ile for sex, age and height or >140/90
- Weight > 300 lbs
- Height < 54"
- Aortic sinus of Valsalva or ascending aorta z-score > 2
- Other cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures, including vigorous exercise
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Pilot Study of Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome
This study plans to learn more about how the energy system works in girls with Turner syndrome. This is important to know so that the investigators understand how Turner syndrome relates to diseases such as diabetes, extra weight gain, heart disease and liver disease, and how this impacts day to day life.
- Conditions
- Turner Syndrome, Turner Syndrome Mosaicism, 45, X/46, XX or XY, Turner Syndrome Mosaicism 46,X,I(X)(Q10)/45,X, Turner Syndrome Karyotype 46,X With Abnormal Sex Chromosome , Except I(Xq)
- Being tested
- No intervention
- Keywords
- Turner syndrome, 45,XO, body composition, cardiometabolism, quality of life, fitness
- Medical subject headings
- Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Adolescents | Adolescents and young adults with Turner syndrome will undergo studies of cardiometabolism, fitness, quality of life questionnaires, and a brief interview. Receives: Other: No intervention | |
| Parents | One parent of a participant will complete parent-report quality of life questionnaires and a brief interview. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption
Peak oxygen consumption (VO2 peak) with a standard graded exercise (bicycle) test
Measured: Baseline
Secondary outcomes (3)
Quality of Life Survey
Self and parent reported quality of life
Measured: Baseline
Percent body fat
Body composition by dual-energy x-ray absorptiometry
Measured: Baseline
Insulin resistance (IR)
Fasting insulin and glucose used to calculate homeostatic model assessment (HOMA)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start26 May 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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 University of Colorado, DenverThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shanlee Davis, MD, MS, Principal investigator, University of Colroado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181230
- Sponsor's protocol ID
- 17-0142
- Other IDs
- UL1TR001082
- Status last verified
- Apr 2021
- First submitted
- 2 Jun 2017
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome
- ClinicalTrials.gov ID
- NCT03181230
- Acronym / sponsor ID
- 17-0142
- Conditions
- Turner Syndrome, Turner Syndrome Mosaicism, 45, X/46, XX or XY, Turner Syndrome Mosaicism 46,X,I(X)(Q10)/45,X, Turner Syndrome Karyotype 46,X With Abnormal Sex Chromosome , Except I(Xq)
- Keywords
- Turner syndrome, 45,XO, body composition, cardiometabolism, quality of life, fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 26 May 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 8 Jun 2017 (actual)
- 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.
This study plans to learn more about how the energy system works in girls with Turner syndrome. This is important to know so that the investigators understand how Turner syndrome relates to diseases such as diabetes, extra weight gain, heart disease and liver disease, and how this impacts day to day life.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | Other: No interventionAdolescents and young adults with Turner syndrome will undergo studies of cardiometabolism, fitness, quality of life questionnaires, and a brief interview. |
| Parents | – | Other: No interventionOne parent of a participant will complete parent-report quality of life questionnaires and a brief interview. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Investigators will enroll adolescent and young adult females with Turner syndrome who will complete all study procedures. One parent will also be enrolled (either mother or father) to complete questionnaires about the daughter.
Key inclusion criteria (4 listed)
- Female
- Age 12-21 years
- 45,XO karyotype in >50% of cells tested with a diagnosis of Turner syndrome (TS)
- Tanner stage 2-5 for breast development
Key exclusion criteria (8 listed)
- Growth hormone treatment within the past 3 months
- Diagnosis of type 1 or type 2 diabetes
- Untreated hypertension with blood pressure > 99%ile for sex, age and height or >140/90
- Weight > 300 lbs
- Height < 54"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Adolescents, Parents |
Primary outcome
Peak oxygen consumption
Time frame: Baseline
Peak oxygen consumption (VO2 peak) with a standard graded exercise (bicycle) test
3 secondary outcomes
Quality of Life Survey
Time frame: Baseline
Percent body fat
Time frame: Baseline
Insulin resistance (IR)
Time frame: Baseline
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 3 May 2021.
- Individual participant dataSharing planned: No
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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.
Shanlee Davis, MD, MS principal investigator
University of Colroado
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 and Turner Syndrome Mosaicism, 45, X/46, XX or XY, run by University of Colorado, Denver 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 8 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 3 May 2021. 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?
Peak oxygen consumption (time frame: Baseline). 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 3 May 2021.