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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT03181230

Collaborator

(none)

Enrollment

Location

19.2

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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)	Other: No intervention

Study Design

Study Type:

Observational

Actual Enrollment :

21 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

May 26, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Adolescents

Adolescents and young adults with Turner syndrome will undergo studies of cardiometabolism, fitness, quality of life questionnaires, and a brief interview.

Other: No intervention

No intervention

Parents

One parent of a participant will complete parent-report quality of life questionnaires and a brief interview.

Other: No intervention

No intervention

Outcome Measures

Primary Outcome Measures

Peak oxygen consumption [Baseline]
Peak oxygen consumption (VO2 peak) with a standard graded exercise (bicycle) test

Secondary Outcome Measures

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)

Other Outcome Measures

Qualitative structured interview [Baseline]
Attitudes surrounding physical activity participation

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 21 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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