Risk of Diabetes in Young Turner Syndrome Patients

August 21, 2017 updated by: Children's Hospital Medical Center, Cincinnati

Beta-Cell Function in Young Turner Syndrome Patients

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

120

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
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Children's Hospital Medical Center, Cincinnati

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

6 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic Turner Syndrome Center of Cincinnati Community Sample

Description

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

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: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 day at screening

Collaborators and Investigators

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

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Nicole Sheanon, MD, Children's Hospital Medical Center, Cincinnati

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 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 10, 2014

First Posted (Estimate)

June 11, 2014

Study Record Updates

Last Update Posted (Actual)

August 23, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHMC-906
  • UL1TR000077 (U.S. NIH Grant/Contract)

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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