Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome
Pilot Study of Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome
2 other identifiers
observational
21
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 26, 2017
CompletedFirst Submitted
Initial submission to the registry
June 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedMay 3, 2021
April 1, 2021
1.6 years
June 2, 2017
April 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak oxygen consumption
Peak oxygen consumption (VO2 peak) with a standard graded exercise (bicycle) test
Baseline
Secondary Outcomes (3)
Quality of Life Survey
Baseline
Percent body fat
Baseline
Insulin resistance (IR)
Baseline
Other Outcomes (1)
Qualitative structured interview
Baseline
Study Arms (2)
Adolescents
Adolescents and young adults with Turner syndrome will undergo studies of cardiometabolism, fitness, quality of life questionnaires, and a brief interview.
Parents
One parent of a participant will complete parent-report quality of life questionnaires and a brief interview.
Interventions
Eligibility Criteria
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.
You may qualify if:
- Female
- Age 12-21 years
- ,XO karyotype in \>50% of cells tested with a diagnosis of Turner syndrome (TS)
- Tanner stage 2-5 for breast development
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Biospecimen
Blood (serum and plasma)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shanlee Davis, MD, MS
University of Colroado
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2017
First Posted
June 8, 2017
Study Start
May 26, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
May 3, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share