Nutritional and metabolic endpoints

None of the metabolic indicators which have been used to date provides a si ngle or necessarily ideal endpoint for interventional management in wasting disorders. Some of these indicators may provide better endpoints for the a cute rather than the chronic wasting conditions. In addition, it is imperat ive that more than one endpoint be selected to be assured that there is con cordance in the findings, However, prior to the selection of any endpoint m easure, the investigators involved must be fully cognizant of the potential pitfalls and errors that can occur in every one of the selected methodolog ies. In anticipating these potential problems, developing strategies for th e interpretation of the data is critical at the outset of any interventiona l management strategy. The manufacturers, the regulators and the investigat ors involved in the interventional management of chronic and acute wasting disorders must agree on the endpoints to be used and these endpoints must p rovide the most appropriate and valid information. Selection of nutritional and metabolic endpoints must be in part dependent on the disease process i nvolved, the potential magnitude of the interventional effect and must be u tilized in the context of a carefully designed experimental protocol with a well focused question(s).