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The increase in the prevalence of obesity has contributed to the increased incidence of prediabetes and type 2 diabetes mellitus among youth and adults. Progressive decline in ß-cell function is now well recognized in children and adults to be pivotal in the progression from normal to abnormal glucose tolerance. Given the increased recognition of the critical role of the ß-cell in the pathogenesis of type 2 diabetes, efforts have begun to shift to prevention of the loss of insulin secretion among individuals at high risk for type 2 diabetes or early stages of the disease. RISE is determining whether medication or surgical intervention strategies can mitigate progressive ß-cell dysfunction in adults and youth with prediabetes or early type 2 diabetes.
The objective of this study is to determine whether medication or surgical intervention strategies can mitigate progressive ß-cell dysfunction in adults and youth with prediabetes or early type 2 diabetes.
Primary aims of the study are to determine whether these intervention strategies can produce a preservation or improvement in ß-cell function lasting at least 3 months following withdrawal of therapy (medication studies) or persisting at 24 months after randomization (surgery study).
Secondary aims of the study are to determine the impact of the interventions on ß-cell function while on active therapy, and also for up to 9 months after withdrawal of medication.
Patients ages 10 to 19 with a diabetes duration of less than 6 months, and patients ages 20-65 with a diabetes duration of less than 1 year may participate in the pediatric and adult medication cohorts. Patients ages 22-65 with a diabetes duration of less than 1 year may participate in the adult surgery cohort.
RISE is determining whether medication or surgical intervention strategies can mitigate progressive ß-cell dysfunction in adults and youth with prediabetes or early type 2 diabetes.
