Risk of Diabetes in Young Turner Syndrome Patients

Turner Syndrome Clinical Trial

Official title:

Beta-Cell Function in Young Turner Syndrome Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160717
• Other study ID #: CCHMC-906
• Secondary ID: UL1TR000077
• Status: Completed
• Phase: N/A
• First received: June 4, 2014
• Last updated: August 21, 2017
• Start date: May 2014
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 6 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome

Locations

Country	Name	City	State
United States	Children's Hospital Medical Center, Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta-Cell Function measured as Disposition Index	Disposition index will be calculated based on the results of the oral glucose tolerance test using minimal modeling (computer program)	1 day at screening