Identification and Treatment of Diabetes In Solid Organ Transplant Recipients

December 7, 2020 updated by: Jee-Young Nina Ham, Emory University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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:

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Children's Center
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta-Egleston

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Participants
Participants will complete tests of glucose tolerance and psychosocial assessments, and will undergo medical history screening. Those children identified with diabetes and/or abnormal glucose tolerance will receive both diabetes self-management education and psychosocial support from a pediatric Certified Diabetes Educator (CDE) and a psychologist, respectively.
Behavioral: Psychologist Support
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.
Behavioral: Pediatric Certified Diabetes Educators (CDEs) Support
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, interval, and end of participation (Up to 18 years of age)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to three years
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.
Up to three years
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.
Up to three years
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.
Baseline, interval, and end of participation (Up to 18 years)
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.
Baseline, interval, and end of participation (Up to 18 years)
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
Baseline, interval, and end of participation (Up to 18 years)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nina Ham, MD, Emory University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 14, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00081257

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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