Articles10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study
Introduction
Prevention of type 2 diabetes mellitus is a major public health challenge because of its large effect on health. Diabetes affected an estimated 171 million people worldwide in 2000, and this number is projected to rise to 366 million by 2030, owing to increases in age, obesity, and urbanisation of the world's population.1 Diabetes was the world's fifth leading cause of death in 2000.2 In the Diabetes Prevention Program (DPP), a US multicentre randomised clinical trial, intensive lifestyle intervention or metformin prevented or delayed development of type 2 diabetes in adults at high risk because of raised fasting plasma glucose (5·3–6·9 mmol/L), impaired glucose tolerance (2-h postload glucose 7·8–11·0 mmol/L), and body-mass index of 24 kg/m2 or higher (≥22 kg/m2 in Asian Americans).3, 4 Development of diabetes5 was the primary outcome, and cardiovascular disease and its risk factors were secondary outcomes.
The Diabetes Prevention Program Outcomes Study (DPPOS) is a long-term follow-up of the DPP to investigate whether the delay in development of diabetes seen during the DPP can be sustained and to assess long-term effects of the interventions on health. In this first phase of DPPOS, we report the intervention effects on diabetes incidence, weight change, and cardiovascular disease risk factors and their treatment during 10 years of follow-up since DPP randomisation.
Section snippets
Participants
Recruitment and random assignment of DPP participants and other study methods have been described.3, 4, 6 We enrolled 3234 participants (68% women, 45% from ethnic and racial minority groups, and 20% aged 60 years or older) between 1996 and 1999. Participants were randomly assigned centrally to one of three interventions: intensive lifestyle (aimed to help participants to achieve and maintain 7% weight loss and 150 min or more per week of moderate-intensity physical activity); metformin 850 mg
Results
Enrolment into this follow-up study from the DPP cohort did not differ significantly by sex or ethnic origin, but was lower in women with a history of gestational diabetes than in those without and higher in participants who had developed diabetes by Sept 1, 2002, than in those without diabetes (table 1). Enrolment was also related to greater age, HbA1c, cholesterol concentrations, and in women, by lower weight and body-mass index (webappendix p 1). Table 2 shows DPPOS baseline characteristics.
Discussion
We report the first phase of the long-term follow-up (DPPOS) of the DPP cohort. The second phase is due to be completed in 2014. The DPP and other clinical trials12, 13, 14, 15, 16 have established the feasibility of interruption of the worsening of hyperglycaemia in overweight people who have raised fasting or postload glycaemia. 10 years after DPP randomisation, cumulative incidence of diabetes remained lower in the lifestyle and metformin groups than in the placebo group, despite changes in
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