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Cited by 725Diabetes, Cardiovascular Risks, and LipoproteinsDiabetes Treatment and ManagementDiabetes Management and Research

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

Open access
·1999·Diabetes Care
DOI 10.2337/diacare.22.4.623PMC PMC1351026
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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, approximately 50% of whom are minority patients and 20% of whom are > or = 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 groups--metformin 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, beta-cell function, insulin sensitivity, obesity, diet, physical activity, and health-related quality of life; and occurrence of adverse events. A fourth treatment group--troglitazone 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.

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  • In the DPP, either intensive lifestyle intervention or metformin stopped or postponed type 2 diabetes among high-risk adults with elevated fasting glucose, impaired glucose tolerance, and raised BMI.

    “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”

    From 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study (2009) · cites this paper as [3]

    The Abstract and Study Design eligibility criteria describe the DPP’s lifestyle and metformin arms and the high-risk participants, including the stated glucose and BMI thresholds. But this 1999 design-and-methods paper says the trial will test whether the interventions prevent or delay diabetes; it does not report that they did so. (LLM, conf=0.90)

    Experimental — accuracy not yet measured

  • The Diabetes Prevention Program was effective for promoting body mass reduction and lessening conversion rates to frank diabetes.

    “The DPP was found to be effective for promoting body mass reduction and lessening the conversion rates to frank diabetes [27,28]”

    From Therapeutic Lifestyle Intervention Targeting Enhanced Cardiometabolic Health and Function for Persons with Chronic Spinal Cord Injury in Caregiver/Care-Receiver Co-Treatment: A Study Protocol of a Multisite Randomized Controlled Trial (2023) · cites this paper as [28]

    The Abstract (page not available) says the DPP will test whether it can prevent or delay diabetes, and the Lifestyle interventions section sets a weight-loss goal. Neither reports achieved weight loss or reduced conversion to diabetes; a search for intervention results found only planned outcomes and expected rates. (LLM, conf=0.76)

    Experimental — accuracy not yet measured

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Cites

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Research works printed but not linked: 5

  1. [7]7. Bailey DJ, Turner RC. Metformin. N Engl J Med 1996;334:574-579. [PubMed: 8569826]
  2. [21]21. Ware JE, Sherbournes CD. The MOS 36 item short form health survey (SR-36). Med Care 1992;30:473-481. [PubMed: 1593914]
  3. [36]36. Flemming TR, Harrington DP. Counting process and survival analysis. New York, Wiley, 1991
  4. [57]57. Widen EIM, Eriksson JG, Groop LC. Metformin normalized nonoxidative metabolism in insulin- resistant normoglycemic relatives of patients with NIDDM. Diabetes 1992;41:354-358. [PubMed: 1551495]
  5. [60]60. Bailey CJ. Metformin C: an update. Gen Pharmac 1993;24:1299-1309.

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Related

Venue
Diabetes Care
Publisher
American Diabetes Association
Published
1999-04-01
Volume
22
Issue
4
Pages
623-634
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/diacare.22.4.623
PMC
PMC1351026
OpenAlex
W2598089744
Semantic Scholar
f64febb2943e9a1363ff6b79a104abc67dfedb0e
Cited by
725
References
75
Citations by year
2026: 15 · 2025: 20 · 2024: 26 · 2023: 36 · 2022: 31 · 2021: 23 · 2020: 30 · 2019: 34 · 2018: 28 · 2017: 36 · 2016: 25 · 2015: 32 · 2014: 30 · 2013: 23 · 2012: 29
FWCI
22.58
Type
journal article
Language
en
Open access
Locations
  • Diabetes Care (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • American Diabetes Association
  • Bristol-Myers Squibb
  • National Institutes of Health
  • Centers for Disease Control and Prevention
  • National Institute of Diabetes and Digestive and Kidney Diseases (U01DK048489)
  • National Institute of Child Health and Human Development
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords
type 2 diabetes prevention, Diabetes Prevention Program, impaired glucose tolerance, prediabetes, metformin, lifestyle intervention, diet and exercise, troglitazone, hepatotoxicity, beta-cell function, insulin sensitivity, cardiovascular risk factors, high-risk individuals, trial design
MeSH terms
Troglitazone, Adult, Aged, Blood Glucose, Energy Intake, Cardiovascular Diseases, Chromans, Diabetes Mellitus, Diabetes Mellitus, Type 2, Exercise Therapy, Female, Glucose Tolerance Test, Health Policy, Humans, Hypoglycemic Agents, Insulin Resistance, Islets of Langerhans, Life Style, Liver, Male, Metformin, Middle Aged, Obesity, Outcome and Process Assessment, Health Care, Quality of Life, Research Design, Risk Factors, Thiazoles, Thiazolidinediones

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