Risk of Diabetes in Young Turner Syndrome Patients | NCT02160717

Studies
Risk of Diabetes in Young Turner Syndrome Patients

NCT02160717

Sponsor

Children's Hospital Medical Center, Cincinnati

Status

Completed

Last Update Posted

Aug 23, 2017Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Turner Syndrome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UL1TR000077	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014Actual

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Jun 4, 2014

First Submission Date that Met QC Criteria

Jun 10, 2014

First Posted Date

Jun 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2017

Last Update Posted Date

Aug 23, 2017Actual

Name	Class
National Center for Advancing Translational Sciences (NCATS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Turner Syndrome		Female with Turner Syndrome
Healthy Controls		Healthy Female

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

22 Years

Standard Ages

ChildAdult

Study Population

Primary Care Clinic Turner Syndrome Center of Cincinnati Community Sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicole Sheanon, MD	Children's Hospital Medical Center, Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Medical Center, Cincinnati		Cincinnati	Ohio	45229	United States

Condition Browse Module

MeSH Terms

ID	Term
D014424	Turner Syndrome
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D006059	Gonadal Dysgenesis
D012734	Disorders of Sex Development
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided