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Risk of Diabetes in Young Turner Syndrome Patients

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT02160717
Collaborator
National Center for Advancing Translational Science (NCATS) (NIH)
120
Enrollment
1
Location
37
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 1, 2014
    Actual Primary Completion Date :
    Jun 1, 2017
    Actual Study Completion Date :
    Jun 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Turner Syndrome

    Female with Turner Syndrome
    Healthy Controls

    Healthy Female

    Outcome Measures

    Primary Outcome Measures

    1. Beta-Cell Function measured as Disposition Index [1 day at screening]

      Disposition index will be calculated based on the results of the oral glucose tolerance test using minimal modeling (computer program)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 22 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT02160717
    Other Study ID Numbers:
    • CCHMC-906
    • UL1TR000077
    First Posted:
    Jun 11, 2014
    Last Update Posted:
    Aug 23, 2017
    Last Verified:
    Aug 1, 2017
    Keywords provided by Children's Hospital Medical Center, Cincinnati
    Turner Syndrome
    Diabetes
    Additional relevant MeSH terms:
    Turner Syndrome
    Gonadal Dysgenesis
    Syndrome

    Study Results

    No Results Posted as of Aug 23, 2017