Risk of Diabetes in Young Turner Syndrome Patients

NCT02160717 | Completed

• 2 other identifiers: CCHMC-906UL1TR000077
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Turner Syndrome

Keywords

Turner Syndrome; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Turner Syndrome

Female with Turner Syndrome

Healthy Controls

Healthy Female

Eligibility Criteria

• Age: 6 Years - 22 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic Turner Syndrome Center of Cincinnati Community Sample

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Children's Hospital Medical Center, Cincinnati

Cincinnati, Ohio, 45229, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Turner Syndrome; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nicole Sheanon, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 11, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 23, 2017

Record last verified: 2017-08

Locations

US (1)