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Completed

NCT Number: NCT03181230

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.

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Key information

Conditions

Turner Syndrome Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Gonadal Dysgenesis Heart Defects, Congenital Heart Diseases Male Urogenital Diseases Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development 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 Urogenital Abnormalities Urogenital Diseases

Age range

12 year–21 year

Sex eligibility

Female

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Peak oxygen consumption

    Time frame: Baseline

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

Secondary outcomes

  1. Quality of Life Survey

    Time frame: Baseline

    Self and parent reported quality of life

  2. Percent body fat

    Time frame: Baseline

    Body composition by dual-energy x-ray absorptiometry

  3. Insulin resistance (IR)

    Time frame: Baseline

    Fasting insulin and glucose used to calculate homeostatic model assessment (HOMA)

Other outcomes

  1. Qualitative structured interview

    Time frame: Baseline

    Attitudes surrounding physical activity participation

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 8, 2017
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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