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Insulin and atherogenesis: clinical trials.

The possible role of hyperinsulinism in the generation and perpetuation of atherosclerosis is discussed. Although the hypothesis is an important one that merits intensive study, it is premature to approach the question through a clinical trial. Rather, a concerted effort should be made to gain more information through basic research in laboratory animals and clinical investigations in man. This basic information will form the foundation upon which future, sound clinical trials may be undertaken. The general characteristics of a sound clinical trial are also discussed. Topics highlighted include the need to define the question to be asked; the intervention to be used; the outcome to be measured; the patient population to be studied, including the necessity of a control group; the eligibility and exclusion criteria for entrance into a study; and basic study design. Each of these topics requires attention and careful planning before a trial is begun. Issues of randomizing patients into treatment groups, maximizing the likelihood of compliance, and the need for quality control and careful monitoring are also reviewed.