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

April 29, 2021 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak oxygen consumption
Time Frame: Baseline
Peak oxygen consumption (VO2 peak) with a standard graded exercise (bicycle) test
Baseline

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative structured interview
Time Frame: Baseline
Attitudes surrounding physical activity participation
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Shanlee Davis, MD, MS, University of Colroado

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-0142
  • UL1TR001082 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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