The Diabetes Prevention Program. Design and methods for a clinical trial in the prevention of type 2 diabetes.

Abstract

The Diabetes Prevention Program is a randomized clinical trial testing strategies to prevent or delay the development of type 2 diabetes in high-risk individuals with elevated fasting plasma glucose concentrations and impaired glucose tolerance. The 27 clinical centers in the U.S. are recruiting at least 3,000 participants of both sexes, ~50% of whom are minority patients and 20% of whom are ≥65 years old, to be assigned at random to one of three intervention groups: an intensive lifestyle intervention focusing on a healthy diet and exercise and two masked medication treatment groupsmetformin or placebo-combined with standard diet and exercise recommendations. Participants are being recruited during a 2 2/3-year period, and all will be followed for an additional 3 1/3 to 5 years after the close of recruitment to a common closing date in 2002. The primary outcome is the development of diabetes, diagnosed by fasting or post-challenge plasma glucose concentrations meeting the 1997 American Diabetes Association criteria. The 3,000 participants will provide 90% power to detect a 33% reduction in an expected diabetes incidence rate of at least 6.5% per year in the placebo group. Secondary outcomes include cardiovascular disease and its risk factors; changes in glycemia, β-cell function, insulin sensitivity, obesity, diet, physical activity, and health-related quality of life; and occurrence of adverse events. A fourth treatment group-troglilazone combined with standard diet and exercise recommendations-was included initially but discontinued because of the liver toxicity of the drug. This randomized clinical trial will test the possibility of preventing or delaying the onset of type 2 diabetes in individuals at high risk. AbbreviationsADA, American Diabetes Association; DPP, Diabetes Prevention Program; FPG, fasting plasma glucose; IGT, impaired glucose tolerance; NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases; OGTT, oral glucose tolerance test; WHO, World Health Organization Type 2 diabetes is a common chronic disease affecting an estimated 12% of 40-to 74-yearold people in the U.S. (1). It is a major cause of premature mortality and morbidity due to cardiovascular, renal, ophthalmic, and neurologic diseases. Although treatment of type 2 diabetes can improve hyperglycemia, normalization of glycemia and glycohemoglobin is rarely achieved or maintained. Furthermore, macro-vascular disease and its risk factors are often already present in individuals at high risk of developing type 2 diabetes (2). Therefore, a policy RESEARCH GOALS PrimaryThe primary research goal is a comparison of the efficacy and safety of each of three interventions (an intensive lifestyle intervention or standard lifestyle recommendations combined with metformin or placebo) in preventing or delaying the development of diabetes. Diabetes is diagnosed by fasting plasma glucose (FPG) or glucose tolerance testing according to the 1997 American Diabetes Association (ADA) criteria (1). SecondarySecondary research goals i...

Effectiveness of the MOVE! Multidisciplinary Weight Loss Program for Veterans in Los Angeles

“…Programs that can help participants achieve weight losses as small as 5% of their body weight can help them reduce the risk of chronic conditions such as type 2 diabetes (10). Intensive interventions such as the Diabetes Prevention Program and the Look Ahead trials have been effective in helping participants achieve clinically significant weight loss (11,12).…”

Prioritized concordance index for hierarchical survival outcomes

“…25 Identifying African-Americans at greatest risk of developing diabetes would allow targeted interventions, such as lifestyle changes or metformin that have been proven to reduce diabetes incidence. 26 In addition to conventional clinical measures such as fasting plasma glucose, two-hour plasma glucose, and glycosylated hemoglobin (HbA 1C ), the DPP clinical trial 19 collected novel clinical measures, such as adiponectin blood level, insulin sensitivity, and CIR on 3234 participants of all races with IGR at enrollment. We evaluate whether these additional clinical measures have improved prognostic ability compared to using conventional clinical measures and demographic covariates alone in 260 African-Americans with IGR assigned to the placebo arm.…”

“…We show that when the primary outcome is rare, the C * index, which incorporates information from auxiliary processes, leads to more accurate and efficient identification of biomarkers that are predictive of all disease outcomes. Using data from the Diabetes Prevention Program (DPP) clinical trial 19 and the C * index, we show that adding certain novel clinical measures (adiponectin blood level, insulin sensitivity, and corrected insulin response [CIR]) to the usual clinical workup may better identify the African-Americans with IGR who are likely to progress to type II diabetes (Section 4). With the extra information from regression to NGR, the C * index significantly detects the added predictive ability of these new clinical measures, which would have been missed using the C index for type II diabetes alone.…”

Implementation of the YMCA Diabetes Prevention Program throughout an Integrated Health System: A Translational Study

“…3 In more than 10 years of randomized trials, the diabetes incidence in high-risk adults was reduced by 34% with intensive lifestyle intervention through the DPP. 4 The DPP as originally constructed 5 was hard to implement and sustain in busy health care settings, where cost was also a major issue. 6 This problem has called for real-world adaptation, as with the Young Men's Christian Association (YMCA) of the USA's customized 52-week version of the program (16 weekly sessions followed by 9 more sessions during the following 8 months), wherein specially trained lifestyle coaches provide mentoring and support to the participants in group settings.…”