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Diabetes autoantibodies do not predict progression to diabetes in adults: the Diabetes Prevention Program.

ABSTRACT: AIMS:To determine if the presence of diabetes autoantibodies predicts the development of diabetes among participants in the Diabetes Prevention Program. METHODS:A total of 3050 participants were randomized into three treatment groups: intensive lifestyle intervention, metformin and placebo. Glutamic acid decarboxylase (GAD) 65 autoantibodies and insulinoma-associated-2 autoantibodies were measured at baseline and participants were followed for 3.2 years for the development of diabetes. RESULTS:The overall prevalence of GAD autoantibodies was 4.0%, and it varied across racial/ethnic groups from 2.4% among Asian-Pacific Islanders to 7.0% among non-Hispanic black people. There were no significant differences in BMI or metabolic variables (glucose, insulin, HbA(1c), estimated insulin resistance, corrected insulin response) stratified by baseline GAD antibody status. GAD autoantibody positivity did not predict diabetes overall (adjusted hazard ratio 0.98; 95% CI 0.56-1.73) or in any of the three treatment groups. Insulinoma-associated-2 autoantibodies were positive in only one participant (0.033%). CONCLUSIONS:These data suggest that 'diabetes autoimmunity', as reflected by GAD antibodies and insulinoma-associated-2 autoantibodies, in middle-aged individuals at risk for diabetes is not a clinically relevant risk factor for progression to diabetes.

SUBMITTER: Dabelea D

PROVIDER: S-EPMC4138247 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Diabetes autoantibodies do not predict progression to diabetes in adults: the Diabetes Prevention Program.

Dabelea D D Ma Y Y Knowler W C WC Marcovina S S Saudek C D CD Arakaki R R White N H NH Kahn S E SE Orchard T J TJ Goldberg R R Palmer J J Hamman R F RF

Diabetic medicine : a journal of the British Diabetic Association 20140409 9

<h4>Aims</h4>To determine if the presence of diabetes autoantibodies predicts the development of diabetes among participants in the Diabetes Prevention Program.<h4>Methods</h4>A total of 3050 participants were randomized into three treatment groups: intensive lifestyle intervention, metformin and placebo. Glutamic acid decarboxylase (GAD) 65 autoantibodies and insulinoma-associated-2 autoantibodies were measured at baseline and participants were followed for 3.2 years for the development of diab ...[more]

PMID: 24646311

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Project description:The largest and longest clinical trial of metformin for the prevention of diabetes is the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study (DPP/DPPOS). In this review, we summarise data from the DPP/DPPOS, focusing on metformin for diabetes prevention, as well as its long-term glycaemic and cardiometabolic effects and safety in people at high-risk of developing diabetes. The DPP (1996-2001) was a RCT of 3234 adults who, at baseline, were at high-risk of developing diabetes. Participants were assigned to masked placebo (n = 1082) or metformin (n = 1073) 850 mg twice daily, or intensive lifestyle intervention (n = 1079). The masked metformin/placebo intervention phase ended approximately 1 year ahead of schedule because of demonstrated efficacy. Primary outcome was reported at 2.8 years. At the end of the DPP, all participants were offered lifestyle education and 88% (n = 2776) of the surviving DPP cohort continued follow-up in the DPPOS. Participants originally assigned to metformin continued to receive metformin, unmasked. The DPP/DPPOS cohort has now been followed for over 15 years with prospective assessment of glycaemic, cardiometabolic, health economic and safety outcomes. After an average follow-up of 2.8 years, metformin reduced the incidence of diabetes by 31% compared with placebo, with a greater effect in those who were more obese, had a higher fasting glucose or a history of gestational diabetes. The DPPOS addressed the longer-term effects of metformin, showing a risk reduction of 18% over 10 and 15 years post-randomisation. Metformin treatment for diabetes prevention was estimated to be cost-saving. At 15 years, lack of progression to diabetes was associated with a 28% lower risk of microvascular complications across treatment arms, a reduction that was no different among treatment groups. Recent findings suggest metformin may reduce atherosclerosis development in men. Originally used for the treatment of type 2 diabetes, metformin, now proven to prevent or delay diabetes, may serve as an important tool in battling the growing diabetes epidemic. Long-term follow-up, currently underway in the DPP/DPPOS, is now evaluating metformin's potential role, when started early in the spectrum of dysglycaemia, on later-stage comorbidities, including cardiovascular disease and cancer.ClinicalTrials.gov NCT00038727 and NCT00004992.

Project description:BackgroundThe Diabetes Prevention Program (DPP) was a randomized, controlled clinical trial. It demonstrated that among high-risk individuals with impaired glucose tolerance, diabetes incidence was reduced by 58 % with lifestyle intervention and 31 % with metformin compared to placebo. During the Diabetes Prevention Program Outcomes Study (DPPOS), all DPP participants were unmasked to their treatment assignments, the original lifestyle intervention group was offered additional lifestyle support, the metformin group continued metformin, and all three groups were offered a group-implemented lifestyle intervention. Over the 10 years of combined DPP/DPPOS follow-up, diabetes incidence was reduced by 34 % in the lifestyle group and 18 % in the metformin group compared to placebo. The purpose of this article is to review and synthesize analyses published by the DPP/DPPOS Research Group that have described the cost-effectiveness of diabetes prevention.MethodsWe describe the resource utilization and costs of the DPP and DPPOS interventions, the costs of non-intervention-related medical care, the impact of the interventions on diabetes progression and quality-of-life, and the cost-effectiveness of the interventions from health system and societal perspectives. Cost-effectiveness analyses were performed with a 3-year time horizon using DPP data, a lifetime time horizon that simulated 3-year DPP data, and a 10-year time horizon using combined DPP/DPPOS data.ResultsAlthough more expensive than the placebo intervention, the greater costs of the lifestyle and metformin interventions were offset by reductions in the costs of nonintervention-related medical care. Every year after randomization, quality-of-life was better for participants in the lifestyle intervention compared to those in the metformin or placebo intervention. In both the simulated lifetime analysis and the 10-year within trial economic analysis, lifestyle and metformin were extremely cost-effective (that is, improved outcomes at a low incremental cost) or even cost-saving (that is, improved outcomes and reduced total costs) compared to the placebo intervention.ConclusionsThe implementation of diabetes prevention programs in high-risk individuals will result in important health benefits and represents a good value for money.Trial registrationNCT00004992 (DPP) and NCT00038727 (DPPOS).

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Diabetes autoantibodies do not predict progression to diabetes in adults: the Diabetes Prevention Program.

Publications

Diabetes autoantibodies do not predict progression to diabetes in adults: the Diabetes Prevention Program.

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