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

Completed

• 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)
• Interventions: Other: No intervention

• Registration Number: NCT03181230
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-26
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-08
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adolescents	No intervention	Adolescents and young adults with Turner syndrome will undergo studies of cardiometabolism, fitness, quality of life questionnaires, and a brief interview.
Parents	No intervention	One parent of a participant will complete parent-report quality of life questionnaires and a brief interview.

Primary Outcome Measures

Name	Time	Method
Peak oxygen consumption	Baseline	Peak oxygen consumption (VO2 peak) with a standard graded exercise (bicycle) test

Secondary Outcome Measures

Name	Time	Method
Quality of Life Survey	Baseline	Self and parent reported quality of life
Percent body fat	Baseline	Body composition by dual-energy x-ray absorptiometry
Insulin resistance (IR)	Baseline	Fasting insulin and glucose used to calculate homeostatic model assessment (HOMA)

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States