Randomized Study of Metformin and Intensive Lifestyle Intervention on Cancer Incidence Over 21 Years of Follow-up in the Diabetes Prevention Program.

Details

• Alternative Title:
  Cancer Prevention Research (Philadelphia, Pa.), 2025, v. 18, no. 7: Randomized Study of Metformin and Intensive Lifestyle Intervention on Cancer Incidence Over 21 Years of Follow-up in the Diabetes Prevention Program.
• Journal Article:
  Cancer Prevention Research (Philadelphia, Pa.)
• Personal Author:
  Heckman-Stoddard, Brandy M ; Crandall, Jill P ; Edelstein, Sharon L ; Prorok, Philip C ; Dabelea, Dana ; Hamman, Richard ; Hazuda, Helen P ; Horton, Edward ; Hoskin, Mary A ; Perloff, Marjorie ; Bowers, Anna ; Knowler, William C ; Ford, Leslie G ; Temprosa, Marinella
• Description:
  Meta-analyses have reported a decrease in overall cancer incidence of approximately 10% to 40% with metformin use among individuals with diabetes. Lifestyle change could potentially reduce cancer incidence. The objective was to determine whether metformin or intensive lifestyle (ILS) intervention reduces the risk of cancer among adults at high risk of diabetes. The Diabetes Prevention Program (1996-2001) randomized 3,234 participants to ILS, metformin (850 mg twice daily), or blinded placebo. During follow-up through the Diabetes Prevention Program Outcomes Study, all participants were offered a modified lifestyle intervention, and metformin continued in an open-label metformin group. Participants reported cancer cases annually. Medical records were adjudicated for all reported events. The primary endpoint was total cancer incidence, comparing metformin versus placebo, with ILS versus placebo as a secondary objective. After a median follow-up of 21 years, 546 participants (173 metformin, 182 ILS, and 191 placebo) were diagnosed with a first incident cancer. Incidence rates of cancer were 9.8, 10.5, and 10.8 per 1,000 person-years in metformin, ILS, and placebo, respectively, with a HR of 0.90 (95% confidence interval, 0.73-1.10) for metformin compared with placebo and 0.96 (95% confidence interval, 0.79-1.18) for ILS compared with placebo. There were no differences between any treatment groups for obesity-related cancer or in sex-specific analyses. Neither assignment to metformin nor ILS reduced cancer incidence among adults at high risk of diabetes. These results may be impacted by increased nonstudy metformin usage over time due to the development of diabetes and reduced intensity of the ILS intervention over time.
  
  This study examines both metformin and ILS intervention as primary cancer prevention interventions in people at high risk for type 2 diabetes.
• Content Notes:
  Author manuscript
• Subjects:
  • Adult
  • Aged
  • Female
  • Humans
  • Male
  • Middle Aged
  • Diabetes Mellitus, Type 2
  • Follow-Up Studies
  • Hypoglycemic Agents
  • Incidence
  More +
• Source:
  Cancer Prevention Research (Philadelphia, Pa.), 2025, v. 18, no. 7
• DOI:
  https://doi.org/10.1158/1940-6207.CAPR-23-0461
• ISSN:
  1940-6207 ; 1940-6215
• Pubmed ID:
  40243198
• Pubmed Central ID:
  PMC12213222
• Document Type:
  Text
• Funding:
  U01 DK048434/DK/NIDDK NIH HHSUnited States/ ; U01DK048339/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01 DK048413/DK/NIDDK NIH HHSUnited States/ ; National Eye Institute (NEI)/ ; U01 DK048339/DK/NIDDK NIH HHSUnited States/ ; American Diabetes Association (ADA)/ ; U01DK048407/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01 DK048468/DK/NIDDK NIH HHSUnited States/ ; U01 DK048387/DK/NIDDK NIH HHSUnited States/ ; U01DK048377/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01 DK048407/DK/NIDDK NIH HHSUnited States/ ; U01 DK048437/DK/NIDDK NIH HHSUnited States/ ; U01 DK048406/DK/NIDDK NIH HHSUnited States/ ; U01DK048381/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01 DK048412/DK/NIDDK NIH HHSUnited States/ ; U01 DK048375/DK/NIDDK NIH HHSUnited States/ ; U01DK048412/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01DK048387/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01DK048434/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U.S. Department of Veterans Affairs (VA)/ ; U01DK048468/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; Indian Health Service (IHS)/ ; U01DK048380/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01DK048411/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01DK048514/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; National Heart, Lung, and Blood Institute (NHLBI)/ ; National Center for Research Resources (NCRR)/ ; Office of Research on Women's Health (ORWH)/ ; U01DK048406/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01 DK048397/DK/NIDDK NIH HHSUnited States/ ; U01 DK048381/DK/NIDDK NIH HHSUnited States/ ; U01DK048489/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01 DK048514/DK/NIDDK NIH HHSUnited States/ ; U01 DK048485/DK/NIDDK NIH HHSUnited States/ ; U01DK048400/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01 DK048411/DK/NIDDK NIH HHSUnited States/ ; U01 DK048443/DK/NIDDK NIH HHSUnited States/ ; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)/ ; U01 DK048380/DK/NIDDK NIH HHSUnited States/ ; U01 DK048400/DK/NIDDK NIH HHSUnited States/ ; U01DK048443/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; Centers for Disease Control and Prevention (CDC)/ ; U01DK048397/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; Z99 CA999999/ImNIH/Intramural NIH HHSUnited States/ ; U01DK048413/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01 DK048404/DK/NIDDK NIH HHSUnited States/ ; U01DK048349/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; National Institute on Minority Health and Health Disparities (NIMHD)/ ; National Cancer Institute (NCI)/ ; National Institute on Aging (NIA)/ ; U01DK048437/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01DK048375/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ ; U01 DK048489/DK/NIDDK NIH HHSUnited States/ ; U01 DK048349/DK/NIDDK NIH HHSUnited States/ ; U01 DK048377/DK/NIDDK NIH HHSUnited States/ ; U01DK048404/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/
• Genre:
  Journal Article
• Pages in Document:
  401-411 (22 pdf pages)
• Volume:
  18
• Issue:
  7
• Download URL:
  https://stacks.cdc.gov/view/cdc/261477/cdc_261477_DS1.pdf
• File Type:
  [PDF - 717.15 KB]
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:e18edc4a0d8a5457ef5569f7001ce558a70bde27581f214eadbb503d92f44384a8e8fb7eaf1a8acc1808840d334ad00427bb7c1e04f38bacd1b3ad2901dc4f15