Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation: A Pilot Study

Memorial Sloan Kettering Cancer Center1 site in 1 country42 target enrollmentSeptember 22, 2014

ConditionsChildhood Cancer Survivors Treated With Abdominal Radiation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Childhood Cancer Survivors Treated With Abdominal Radiation
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 42
Locations: 1
Primary Endpoint: characterize β cell function
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to better understand the risk factors and causes of diabetes in people who received radiation to the abdomen as children. The investigators hope this information will allow them to improve how they screen people at risk for diabetes and how they treat patients in the future.

Registry

clinicaltrials.gov

Start Date

September 22, 2014

End Date

October 9, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of childhood cancer between 0-21 years of age
•Prior treatment with abdominal radiation at MSKCC
•Two or more years from completion of therapy
•Records of cancer diagnosis and treatment (including radiation records) available

Exclusion Criteria

•Known diagnosis of diabetes
•Previous treatment with any radiation impacting the brain (cranial radiation, craniospinal radiation, total body irradiation)
•Neurocognitive deficits that impair ability to give informed consent or assent
•Patients predicted to have difficult intravenous access, who will likely require multiple venipuncture attempts

Outcomes

Primary Outcomes

characterize β cell function

Time Frame: 2 years

we will be able to estimate the proportion of patients with abnormalities of insulin sensitivity or β cell function, as assessed by the OGTT, to within ± 0.14.

insulin sensitivity

Time Frame: 2 years

we will be able to estimate the proportion of patients with abnormalities of insulin sensitivity or β cell function, as assessed by the OGTT, to within ± 0.14.