title: Clinical trials in youth with type 2 diabetes.
abstract: Type 2 diabetes in youth was almost unheard of only two decades ago. However, tracking the recent dramatic rise in childhood obesity, type 2 diabetes has become increasingly prevalent. Thus, there is an urgent need for high-quality clinical trials to increase in-depth knowledge about pathophysiology, optimal treatment, and prevention. We therefore systematically reviewed published and ongoing clinical trials of type 2 diabetes in children and adolescents. The results demonstrate that (i) few randomized clinical trials have been completed and published in children with type 2 diabetes; (ii) ongoing trials in type 1 diabetes clearly outnumber trials in type 2 diabetes; and (iii) recruitment and enrollment into the latter trials are challenging, however once achieved, drop-out rates are not excessively high. We conclude that type 2 diabetes in youth is an important but difficult new field of clinical research, and we discuss the existing barriers to successful recruitment, conduct, and support of these clinical trials.
authors.affiliation: Clinical Endocrinology Branch, National Institute of Diabetes, Digestive and Kidney Diseases, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892, USA.
authors.forename: Julie Anne L
authors.initials: JA
authors.lastname: Gemmill
authors.forename: Rebecca J
authors.initials: RJ
authors.lastname: Brown
authors.forename: Radha
authors.initials: R
authors.lastname: Nandagopal
authors.forename: Luisa M
authors.initials: LM
authors.lastname: Rodriguez
authors.forename: Kristina I
authors.initials: KI
authors.lastname: Rother
mesh_terms: D000293:Adolescent; D002648:Child; D002986:Clinical Trials as Topic; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D006801:Humans; D018579:Patient Selection; D012307:Risk Factors
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