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Case Study 2: Insulin Clamp, Body Mass Index and Risk of Diabetes

Case Study 2: Insulin Clamp, Body Mass Index and Risk of Diabetes. Moderator: Ms. Victoria Pemberton, NIH/NHLBI. Case Study 2: Insulin Clamp, Body Mass Index (BMI) and Risk of Diabetes. Moderator: Victoria Pemberton, NIH/NHLBI Panelists: Sandra Alfano, Yale School of Medicine, IRB Chair

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Case Study 2: Insulin Clamp, Body Mass Index and Risk of Diabetes

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  1. Case Study 2: Insulin Clamp, Body Mass Index and Risk of Diabetes Moderator: Ms. Victoria Pemberton, NIH/NHLBI

  2. Case Study 2: Insulin Clamp, Body Mass Index (BMI) and Risk of Diabetes • Moderator: Victoria Pemberton, NIH/NHLBI • Panelists: • Sandra Alfano, Yale School of Medicine, IRB Chair • Silva Arslanian, University of Pittsburgh, Professor of Pediatrics, Director of Pediatric Clinical and Translational Research Center (CTSA) • Sandy Vasan, The Rockefeller University, Pediatric Consultant to IRB • Lisa Teot, University of Pittsburgh, Pediatric Pathologist & Scientific IRB Member • Richard Guido, University of Pittsburgh, IRB Chairman, Magee-Women’s Hospital • David Asmuth, University of California, Davis, IRB Chair • Description of the case: • The study is designed to determine if an insulin clamp plus a combination of lipid profile, blood pressure and BMI can accurately predict the likelihood of onset of Type 2 diabetes, in children 11 years of age with varying BMIs. • The study procedure involves an overnight fast, insertion of two catheters, and heating one hand via a heated box or heat pad for the duration of the test. Potential risks include hypoglycemia, heat burns and complications from the insertion of two intravenous catheters.

  3. Details of Case Study # 2 • Objectives: Determine the predictive value of insulin clamp studies with serum lipid profile, blood pressure and BMI for risk of onset of Type 2 diabetes • Hypothesis: Insulin clamp plus a combination of lipid profile, blood pressure and BMI can accurately predict the likelihood of onset of Type 2 diabetes by age 21 • Population: 11 year old children in different BMI strata using CDC charts- 5th to 85th percentile (normal), 86th to 95th percentile (at risk for overweight), > 95th percentile (overweight) • Design: Single arm with single assessment with longitudinal follow up • Therapeutic Intervention: None • Assessments: Insulin clamp studies, anthropometric assessment, biochemical laboratory studies • Primary Outcomes: • Association of insulin clamp results with risk factors for development of Type 2 diabetes • Rate and time of onset of Type 2 diabetes by age 21

  4. Pediatric Research Regulations Related to the Case • 45 CFR 46.404 research not involving greater than minimal risk • 45 CFR 46.405 research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects • 45 CFR 46.406 research involving a minor increase over minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition • 45 CFR 46.407 research not otherwise approvable which presents an opportunity to understand, prevent or alleviate a serious problem affecting the health or welfare of children

  5. Key Issues for Case Study # 2 • How does the panel assess risk in this case? • Is the risk assessment different between any of the subgroups considered for enrollment in this study? • Are there previous studies or additional information that might help the panel to assess risk in this particular study? • Does this study require a 407 review? • Should normal, healthy children be included in this study? • Should children “at risk” such as overweight be included in this study? • Is it scientifically feasible to include only children with a family history of Type 2 diabetes? • Are there changes that could be proposed to allow this study to be conducted while maintaining its scientific value?

  6. References • Office for Human Research Protections (OHRP) Precursors to Diabetes in Japanese American Youth 407 Review (2003) http://www.hhs.gov/ohrp/children/japanese.html • Sinaiko, A, Jacobs, D, Steinberg, J, Moran, A, Luepker, R, Rocchini, A, and Prineas, R. (2001). Insulin resistance syndrome in childhood: Associations of the euglycemic insulin clamp and fasting insulin with fatness and other risk factors.J. Peds; 139(5):700-707. • Wendler, D, Belsky, L, Thompson, KM, and Emanuel, EJ. (2005). Quantifying the federal minimal risk standard: Implications for pediatric research without a prospect of direct benefit. JAMA; 294:826-832.

  7. Question for the Audience • Would you approve normal healthy children enrolling in this study? • Individual Yes Votes: 9 • Multiple Person Yes Votes: 4 • Individual No Votes: 26 • Multiple Person No Votes: 5

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