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Clinical Trial
. 2005 Apr 19;142(8):611-9.
doi: 10.7326/0003-4819-142-8-200504190-00009.

The effect of metformin and intensive lifestyle intervention on the metabolic syndrome: the Diabetes Prevention Program randomized trial

Trevor J Orchard  1 , Marinella Temprosa, Ronald Goldberg, Steven Haffner, Robert Ratner, Santica Marcovina, Sarah Fowler; Diabetes Prevention Program Research Group
Affiliations
Clinical Trial

The effect of metformin and intensive lifestyle intervention on the metabolic syndrome: the Diabetes Prevention Program randomized trial

Trevor J Orchard et al. Ann Intern Med. .

Abstract

Background: The metabolic syndrome is a high-risk state for diabetes and cardiovascular disease. Little is known about its prevalence and prevention in those with impaired glucose tolerance.

Objective: To determine the prevalence of the metabolic syndrome at baseline in the Diabetes Prevention Program and the effect of intensive lifestyle intervention and metformin therapy on the syndrome's incidence and resolution.

Design: Randomized, controlled clinical trial.

Setting: Research and community-based centers.

Participants: Participants had impaired glucose tolerance (World Health Organization criteria plus fasting plasma glucose level >or=5.3 mmol/L [>or=95 mg/dL]) and were followed for a mean of 3.2 years after random assignment to intensive lifestyle intervention, metformin therapy, or placebo.

Interventions: Metformin, 850 mg twice daily, or intensive lifestyle intervention designed to achieve and maintain a 7% weight loss and 150 minutes of exercise per week.

Measurements: The metabolic syndrome was defined as having 3 or more characteristics (waist circumference; blood pressure; and levels of high-density lipoprotein cholesterol, triglycerides, and fasting plasma glucose) that met criteria from the National Cholesterol Education Program Adult Treatment Panel III.

Results: Fifty-three percent of participants (n = 1711) had the metabolic syndrome at baseline; incidence did not vary substantially by age. However, low levels of high-density lipoprotein cholesterol predominated in younger participants (age 25 to 44 years), and high blood pressure predominated in older participants (age 60 to 82 years). In life-table analyses (log-rank test), incidence of the metabolic syndrome was reduced by 41% in the lifestyle group (P < 0.001) and by 17% in the metformin group (P = 0.03) compared with placebo. Three-year cumulative incidences were 51%, 45%, and 34% in the placebo, metformin, and lifestyle groups, respectively. There was no significant heterogeneity by ethnic group.

Limitations: The study involved a volunteer group with impaired glucose tolerance, which limits generalizability.

Conclusions: The metabolic syndrome affected approximately half of the participants in the Diabetes Prevention Program at baseline. Both lifestyle intervention and metformin therapy reduced the development of the syndrome in the remaining participants.

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Conflict of interest statement

Potential Financial Conflicts of Interest: Consultancies: T.J. Orchard (Metabolic Syndrome Alliance, Sanofi-Aventis); Grants received: R. Ratner (Bristol-Myers Squibb).

Figures

Figure 1
Figure 1
Randomly assigned participants by treatment group and annual visit.
Figure 2
Figure 2
Development of the metabolic syndrome by intervention group in the Diabetes Prevention Program.
Figure 3
Figure 3
Resolution of the metabolic syndrome by intervention group in the Diabetes Prevention Program.
See this image and copyright information in PMC

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References

    1. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III) JAMA. 2001;285:2486–2497. [PMID: 11368702] - PubMed
    1. Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998;15:539–553. [PMID: 9686693] - PubMed
    1. Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA. 2002;287:356–359. [PMID: 11790215] - PubMed
    1. Alexander CM, Landsman PB, Teutsch SM, Haffner SM. NCEP-defined metabolic syndrome, diabetes, and prevalence of coronary heart disease among NHANES III participants age 50 years and older. Diabetes. 2003;52:1210–1214. [PMID: 12716754] - PubMed
    1. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346:393–403. [PMID: 11832527] - PMC - PubMed

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