Dataset Information

Changes in albumin excretion in the diabetes prevention program.

ABSTRACT:

Objective

Increased urinary albumin excretion rates have been linked to nephropathy and macrovascular disease. We here describe the baseline prevalence and effect of Diabetes Prevention Program (DPP) interventions on the development and reversal of elevated albumin excretion.

Research design and methods

Urine albumin-to-creatinine ratios (ACRs) were calculated from untimed urine collections. Analyses compared participants by treatment group, diabetes and hypertension status, and use of ACE inhibitors or angiotensin II receptor blockers (ARBs).

Results

Elevated ACR levels (>or=30 mg/g creatinine) were present at baseline in 198 (6.2%) of 3,188 participants: placebo 5.3%, metformin 6.5%, and intensive lifestyle (ILS) 6.8%. Of the 2,802 with ACR measurements at baseline and at the end of the study, the percentage with elevated levels declined (incident and regression) from 6.2 to 6.1%, with no significant differences between the groups even with adjustment for ACE inhibitor and ARB use. The odds of developing an elevated ACR were 59% higher for a participant who developed diabetes compared with one who did not.

Conclusions

At entry into the DPP, an elevated ACR was present in 6.2%. Despite the marked decrease in progression to diabetes and the improvement in insulin resistance and other cardiovascular risk markers in the ILS and metformin groups, there was no improvement in ACR, on average, in those two groups. However, the frequency of an elevated ACR was higher in participants who developed diabetes. An increased ACR may have multiple causes, thus obscuring the improvements that might have been expected with the reduction in insulin resistance seen in the DPP.

SUBMITTER: Diabetes Prevention Program Research Group

PROVIDER: S-EPMC2660489 | biostudies-literature | 2009 Apr

REPOSITORIES: biostudies-literature

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Publications

Changes in albumin excretion in the diabetes prevention program.

Diabetes care 20090108 4

<h4>Objective</h4>Increased urinary albumin excretion rates have been linked to nephropathy and macrovascular disease. We here describe the baseline prevalence and effect of Diabetes Prevention Program (DPP) interventions on the development and reversal of elevated albumin excretion.<h4>Research design and methods</h4>Urine albumin-to-creatinine ratios (ACRs) were calculated from untimed urine collections. Analyses compared participants by treatment group, diabetes and hypertension status, and u ...[more]

PMID: 19131464

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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.Trial registrationClinicalTrials.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).

Dataset Information

Changes in albumin excretion in the diabetes prevention program.

Objective

Research design and methods

Results

Conclusions

Publications

Changes in albumin excretion in the diabetes prevention program.

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