Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation

Study Overview
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Brief Summary
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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.

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

Conditions
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Childhood Cancer Survivors Treated With Abdominal Radiation

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treated < 20 years prior to study enrollment<br>The following information will be gathered: A. Height, weight, waist circumference, blood pressure B. Oral glucose tolerance testing (OGTT) where in participants will ingest a standard oral glucose load (75 grams) in liquid formulation after an overnight fast. Blood samples for glucose and insulin concentrations will be taken at 0, 30, 60, 90, and 120 minutes post-glucose load. C. Glutamic acid decarboxylase (GAD), islet cell (ICA-512), and insulin autoantibody (IAA) titers as well as serum adiponectin and hemoglobin A1c. All enrolled patients will have a discussion with an LTFU doctor regarding the results of testing. Counseling and referral to a specialist will be provided if indicated. | |
| treated ≥ 20 years prior to study enrollment<br>The following information will be gathered: A. Height, weight, waist circumference, blood pressure B. Oral glucose tolerance testing (OGTT) where in participants will ingest a standard oral glucose load (75 grams) in liquid formulation after an overnight fast. Blood samples for glucose and insulin concentrations will be taken at 0, 30, 60, 90, and 120 minutes post-glucose load. C. Glutamic acid decarboxylase (GAD), islet cell (ICA-512), and insulin autoantibody (IAA) titers as well as serum adiponectin and hemoglobin A1c. All enrolled patients will have a discussion with an LTFU doctor regarding the results of testing. Counseling and referral to a specialist will be provided if indicated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characterize β cell function | 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. | 2 years | 
| insulin sensitivity | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Risk, 14-202