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Risk of Diabetes in Young Turner Syndrome Patients

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ClinicalTrials.gov Identifier: NCT02160717
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
Turner Syndrome is a common genetic disorder. Seventy percent of adults with Turner Syndrome have abnormalities in glucose metabolism which can lead to diabetes. The current screening guidelines for diabetes in Turner Syndrome are not specific and involve a fasting blood sugar once a year. The objective of this study is to determine if there are abnormalities in glucose metabolism and pancreatic function in young girls with Turner Syndrome. The study hypothesis is that pancreatic dysfunction (specifically of the beta cells that make insulin) is more prevalent in girls with Turner Syndrome compared to healthy controls.

Condition or disease
Turner Syndrome

Detailed Description:
The study will be conducted at Children's Hospital Medical Center, Cincinnati. The study will require 1 visit to the hospital where the subject will have an oral glucose tolerance test and a physical exam

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Beta-Cell Function in Young Turner Syndrome Patients
Actual Study Start Date : May 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


Group/Cohort
Turner Syndrome
Female with Turner Syndrome
Healthy Controls
Healthy Female



Primary Outcome Measures :
  1. Beta-Cell Function measured as Disposition Index [ Time Frame: 1 day at screening ]
    Disposition index will be calculated based on the results of the oral glucose tolerance test using minimal modeling (computer program)


Biospecimen Retention:   Samples Without DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic Turner Syndrome Center of Cincinnati Community Sample
Criteria

Turner Syndrome Females:

Inclusion Criteria:

  • Turner Syndrome confirmed by chromosomal testing
  • On standard therapy (growth hormone and or estrogen)

Exclusion Criteria:

  • Type 1 or Type 2 diabetes
  • Polycystic Ovarian Syndrome
  • Pregnancy
  • On any medications that alter blood sugar

Healthy Female Controls:

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Type 1 or Type 2 diabetes
  • Polycystic Ovarian Syndrome
  • Pregnancy
  • On any medications that alter blood sugar

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160717


Locations
United States, Ohio
Children's Hospital Medical Center, Cincinnati
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Center for Advancing Translational Science (NCATS)
Investigators
Principal Investigator: Nicole Sheanon, MD Children's Hospital Medical Center, Cincinnati

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02160717     History of Changes
Other Study ID Numbers: CCHMC-906
UL1TR000077 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Turner Syndrome
Diabetes

Additional relevant MeSH terms:
Syndrome
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Disease
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female