Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome

Turner Syndrome Clinical Trial

Official title:

Pilot Study of Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181230
• Other study ID #: 17-0142
• Secondary ID: UL1TR001082
• Status: Completed
• Start date: May 26, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 21 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Syndrome
• Turner Syndrome
• Turner Syndrome Karyotype 46,X With Abnormal Sex Chromosome , Except I(Xq)
• Turner Syndrome Mosaicism 46,X,I(X)(Q10)/45,X
• Turner Syndrome Mosaicism, 45, X/46, XX or XY

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative structured interview	Attitudes surrounding physical activity participation	Baseline
Primary	Peak oxygen consumption	Peak oxygen consumption (VO2 peak) with a standard graded exercise (bicycle) test	Baseline
Secondary	Quality of Life Survey	Self and parent reported quality of life	Baseline
Secondary	Percent body fat	Body composition by dual-energy x-ray absorptiometry	Baseline
Secondary	Insulin resistance (IR)	Fasting insulin and glucose used to calculate homeostatic model assessment (HOMA)	Baseline