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

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

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.

Study Overview

• Status: Completed
• Conditions: Childhood Cancer Survivors Treated With Abdominal Radiation

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Childhood cancer survivors followed by the Pediatric Long-Term Follow-Up Program or Adult Long-Term Follow-Up Program will be recruited for the current study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
treated < 20 years prior to study enrollment; 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; 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?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Danielle N. Friedman, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2014
• Primary Completion (Actual): October 9, 2019
• Study Completion (Actual): October 9, 2019

Study Registration Dates

• First Submitted: September 22, 2014
• First Submitted That Met QC Criteria: September 22, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes Risk; 14-202
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: 14-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No