NON-INSULIN DEPENDENT DIABETES MELLITUS (NIDDM) PRIMARY PREVENTION TRIAL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: As part of a multi-center grant (DK-93-07, non-insulin dependent diabetes mellitus primary prevention trial), we will attempt to prevent the development of NIDDM in 200 subjects with impaired glucose tolerance. RESEARCH PLAN: The Diabetes Prevention Trial (DPP) is a large multi-center study that tested the hypothesis that the use of intensive lifestyle modification or medications (metformin) could delay or prevent the onset of type 2 diabetes in persons who are at high risk for its development by virtue of having impaired glucose tolerance (IGT). Impaired glucose tolerance represents a less severe stage of blood glucose abnormalities and often precedes type 2 diabetes. METHODS: The primary research question for the DPP Trial is to determine the safety and efficacy of two interventions (intensive lifestyle or metformin) relative to a control intervention (standard lifestyle modifications) in delaying or preventing the onset of type 2 diabetes. Secondary endpoints include changes in lipids, lipoproteins, ankle/arm ratio, urinary albumin, and carotid wall thickness. Subjects will be obtained by several methods including: (a) community advertising through radio and television advertisements; (b) selective screening base from the University Center Downtown; and (c) subjects from the San Antonio Heart Study. Subjects identified with newly discovered diabetes but with normal fasting glycemia (2-hr glucose = 200 mg/dl, but fasting glucose 140 mg/dl) will be entered into a parallel secondary prevention trial to prevent the development of fasting hyperglycemia. In addition to the endpoints for the subjects in the primary prevention trial, these subjects will have assessment for diabetic neuropathy and retinopathy.