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NCT03181230 Clinical Trial

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
Phase
First received
Last updated
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
Health authority
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

Study Design

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
See also
  Status Clinical Trial Phase
Completed NCT01734486 - Growth Response in Girls With Turner Syndrome Phase 4
Completed NCT01678261 - X-chromosome Inactivation, Epigenetics and the Transcriptome N/A
Completed NCT01419249 - First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study Phase 4
Completed NCT01518036 - Use of Somatropin in Turner Syndrome Phase 3
Recruiting NCT04948658 - Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Completed NCT01563926 - Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency Phase 3
Completed NCT02787486 - Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
Completed NCT00877942 - Sex Differences in Early Brain Development; Brain Development in Turner Syndrome N/A
Completed NCT00825617 - Quantitative Liver Functions in Turner Syndrome With and Without Hormone Replacement Therapy N/A
Recruiting NCT04463316 - GROWing Up With Rare GENEtic Syndromes
Enrolling by invitation NCT03836300 - Parent and Infant Inter(X)Action Intervention (PIXI) N/A
Completed NCT01245374 - Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents Phase 4
Completed NCT01322165 - National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions N/A
Terminated NCT00419107 - Beta Cell Function in Women With Turner Syndrome N/A
Active, not recruiting NCT00625001 - Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome N/A
Completed NCT00029159 - The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome Phase 3
Completed NCT01518062 - Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome Phase 4
Completed NCT00471731 - Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure N/A
Completed NCT00256126 - Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN® Phase 4
Completed NCT02160717 - Risk of Diabetes in Young Turner Syndrome Patients N/A