DIABETES PREVENTION PROGRAM OUTCOMES STUDY (DPPOS)

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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. The long-term follow-up study of the DPP, entitled the Diabetes Prevention Program Outcomes Study or DPPOS, is designed to take further advantage of the scientifically and clinically valuable cohort of DPP volunteers and the large volume of data collected during the study to address the issues above. The highly complaint DPP cohort, including 45% minorities, is the largest IGT population ever studied. Moreover, the large number of new onset Type 2 diabetic patients, carefully followed from near the time of their true onset, provides an unparalleled opportunity to study the clinical course of Type 2 diabetes. Objectives: The primary objective of the DPPOS is to evaluate the long-term effects of active DPP interventions on the development of a) diabetes during a further 5-10 years of follow-up and b) composite diabetes-related microangiopathic and cardiovascular disease outcomes. The hypotheses being tested are that both the continued lifestyle intervention and metformin will provide continued separation in the rates of diabetes development, compared with the former placebo group, and that the prevention or delay of diabetes during the DPP and DPPOS will translate into reduced rates of composite outcomes and improved health status. The secondary objectives of the DPPOS are to evaluate the long-term effects of DPP interventions on selected individual health outcomes, the established and putative risk factors for those outcomes, and the costs and cost-utility associated with delay or prevention of diabetes. Other research objectives include examining and comparing the incidence and determinants of these health outcomes in participants with new-onset diabetes and IGT, as well as assessing subgroups of participants in order to evaluate the effect of race/ethnicity and gender on health outcomes. All DPP participants, including those previously assigned to intensive lifestyle, metformin, troglitazone, and placebo, whether or not they developed diabetes during the DPP, are eligible and will be invited to join DPPOS. Based on the baseline characteristics of the DPP cohort, the mean age of the study population will be 55 years, with 67% being women. Fifty-four percent are Caucasian, 20% African-American, 16% Hispanic American, 4% Asian or Pacific Islander-American, and 5% American Indian. Approximately 750 participants will have been diagnosed as having diabetes during the previous 4-6 years. Study Interventions: During DPPOS, quarterly group meetings will be held for all participants. These will focus on lifestyle lectures as well as other topics of interest in participants with IGT or diabetes. Additional group lifestyle booster sessions will be offered to the group originally assigned to intensive lifestyle intervention and open label metformin therapy (850 mg twice per day) will continue to be provided to the participants originally assigned to metformin. Outcomes: The diabetes outcome is the same as the primary outcome during the DPP, i.e. development of diabetes according to American Diabetes Association criteria (fasting plasma glucose level 126 mg/dL [7.0 mmol/L] or 2-hour plasma glucose 200 mg/dL [11.1 mmol/L], after a 75 gram OGTT and confirmed with a repeat test). The composite diabetes-related outcomes are defined as: a. Microvascular: including having one or more of the following: development of any retinopathy characteristic of diabetes detected by retinal photographs, a score 2 on the Michigan Neuropathy Screening Index (MNSI), the development of albuminuria (30 mg/gram creatinine), or renal dysfunction (end-stage renal disease or creatinine 2 mg/dL); and b. Macrovascular: Including having one or more of the following: cardiovascular disease (CVD) events (fatal and non-fatal myocardial infarction and stoke), silent MI on EKG, coronary artery stenosis 50% documented by angiography, coronary revascularization, absolute value of or change in carotid ultrasound measured intimal-medial thickness, either ICA or CCA, that equals or exceeds a value known to be clinical relevant based on emerging research, or an ankle: brachial blood pressure ratio 0.9. Secondary outcomes are: a. Diabetic retinopathy b. Loss of vision c. Diabetic neuropathy d. Albuminuria e. Renal failure f. Cardiovascular disease events g. Subclinical atherosclerosis outcomes h. Risk factors for cardiovascular disease, including risk profiles