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Completed

NCT Number: NCT02605200

Identification and Treatment of Diabetes In Solid Organ Transplant Recipients

The purpose of this study is to determine the influence of post-transplant diabetes on medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to 18 years of age and their families.

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Key information

Conditions

Complications of Transplanted Organs and Tissue Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta-Egleston, Atlanta, Georgia, United States

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About this study

This study seeks to understand how organ transplant patients are affected by the development of diabetes, and to test whether early diagnosis of diabetes and comprehensive professional support will:

  • facilitate the adjustment of children and their families to the rigors of diabetes care
  • improve adherence to medication regimens
  • reduce acute complications of diabetes and organ rejection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of Children's Healthcare of Atlanta who have received a kidney, liver, or heart transplant

Exclusion criteria

  • Received a transplant after 18 years of age
  • Cognitively unable to participant as determined by the study team psychologist
  • Not receiving a solid organ transplant for kidney, liver, or heart
  • Declines participation invitation

Treatment and study plan

Psychologist Support

Behavioral

Participants will complete several psychological questionnaires that are intended to cover a broad spectrum of physical, mental, and emotional aspects of the health of participants; the Behavior Assessment System for Children (BASC) ,the Children Depression Inventory (CDI 2), the Pediatric Quality of Life Inventory Transplant Module (PedsQL), and the Wechsler Abbreviated Scale of Intelligence II (WASI-II). Data gathered from this testing will be used to guide the provision of psychological care to address psychosocial challenges inherent to the care of children with transplant related diabetes.

Pediatric Certified Diabetes Educators (CDEs) Support

Behavioral

Pediatric Certified Diabetes Educators (CDEs) are specially trained to teach diabetes self-management to children and their families. Participants who are diagnosed with diabetes will receive individualized support from a CDE in conjunction with their routine transplant care.

Primary outcomes

  1. Change in the Pediatric Quality of Life Inventory Transplant Module (PedsQL)

    Time frame: Baseline, interval, and end of participation (Up to 18 years of age)

    The Pediatric Quality of Life Inventory Transplant Module (PedsQL) is a 15 minute survey intended to measure emotional and physical function in children and determine state of wellbeing.

Secondary outcomes

  1. Transplant Rejection Rate Post Diabetes Diagnosis

    Time frame: Up to three years

    Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of transplant rejection after being diagnosed with diabetes.

  2. Rate of Vascular Disease Post Diabetes Diagnosis

    Time frame: Up to three years

    Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of vascular disease after being diagnosed with diabetes.

  3. Mortality Rate Post Diabetes Diagnosis

    Time frame: Up to three years

    Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of mortality after being diagnosed with diabetes.

  4. Change in the Wechsler Abbreviated Scale of Intelligence II (WASI-II) Score

    Time frame: Baseline, interval, and end of participation (Up to 18 years)

    The Wechsler Abbreviated Scale of Intelligence II (WASI-II) is intended to determine cognitive ability for use in educational, as well as clinical and research settings. The WASI-II is ideal for any subject over the age of six, and takes approximately one hour to complete.

  5. Change in the Children Depression Inventory (CDI 2) Score

    Time frame: Baseline, interval, and end of participation (Up to 18 years)

    The Children Depression Inventory (CDI 2) is a short ten minute self-reported survey intended to aid in the assessment of signs of depression in children ages seven through 17. This test helps determine negative mood, poor self-esteem, a loss of interest in activities, interpersonal problems, and feelings of ineffectiveness, the common traits of depression.

  6. Change in the Behavior Assessment System for Children (BASC) Score

    Time frame: Baseline, interval, and end of participation (Up to 18 years)

    The Behavior Assessment System for Children (BASC) takes approximately 15 minutes to complete and is intended to determine emotional and behavioral change in children, as well as to indicate risks to their health and development

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 16, 2015
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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