Corrine I Voils1,2, Cynthia J Coffman3,4, Janet M Grubber5, David Edelman6,7, Azita Sadeghpour8, Matthew L Maciejewski9,10, Jamiyla Bolton11, Alex Cho12, Geoffrey S Ginsburg13,14, William S Yancy15,16. 1. Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, 508 Fulton St., Durham, NC, 27705, USA. corrine.voils@dm.duke.edu. 2. Department of Medicine, Duke University Medical Center, Durham, NC, 27710, USA. corrine.voils@dm.duke.edu. 3. Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, 508 Fulton St., Durham, NC, 27705, USA. cynthia.coffman@duke.edu. 4. Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA. cynthia.coffman@duke.edu. 5. Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, 508 Fulton St., Durham, NC, 27705, USA. janet.grubber@va.gov. 6. Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, 508 Fulton St., Durham, NC, 27705, USA. dedelman@duke.edu. 7. Department of Medicine, Duke University Medical Center, Durham, NC, 27710, USA. dedelman@duke.edu. 8. Department of Medicine, Duke University Medical Center, Campus Box 3709, Durham, NC, 27710, USA. azita.sadeghpour@duke.edu. 9. Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, 508 Fulton St., Durham, NC, 27705, USA. matthew.maciejewski@va.gov. 10. Department of Medicine, Duke University Medical Center, Durham, NC, 27710, USA. matthew.maciejewski@va.gov. 11. Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, 508 Fulton St., Durham, NC, 27705, USA. jamiyla.bolton@va.gov. 12. Department of Medicine, Duke University Medical Center, 3100 Tower Blvd, Suite 600, DUMC Box 3329, Durham, NC, 27707, USA. alex.cho@duke.edu. 13. Department of Medicine, Duke University Medical Center, Durham, NC, 27710, USA. geoffrey.ginsburg@duke.edu. 14. Center for Personalized and Precision Medicine, 101 Science Dr, Rm 2111, CIEMAS Bldg, Duke Box 3382, Durham, NC, 27708, USA. geoffrey.ginsburg@duke.edu. 15. Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, 508 Fulton St., Durham, NC, 27705, USA. yancy006@mc.duke.edu. 16. Department of Medicine, Duke University Medical Center, Durham, NC, 27710, USA. yancy006@mc.duke.edu.
Abstract
OBJECTIVE: We examined the clinical utility of supplementing type 2 diabetes mellitus (DM) risk counseling with DM genetic test results and counseling. RESEARCH DESIGN AND METHODS: In this randomized controlled trial, non-diabetic overweight/obese veteran outpatients aged 21 to 65 years received DM risk estimates for lifetime risk, family history, and fasting plasma glucose, followed by either genetic test results (CR+G; N = 303) or control eye disease counseling (CR+EYE; N = 298). All participants received brief lifestyle counseling encouraging weight loss to reduce the risk of DM. RESULTS:The mean age was 54 years, 53% of participants were black, and 80% were men. There was no difference between arms in weight (estimated mean difference between CR+G vs. CR+EYE at 3 months = 0.2 kg, 95% CI: -0.3 to 0.7; at 6 months = 0.4 kg, 95 % CI: -0.3 to 1.1), insulin resistance, perceived risk, or physical activity at 3 or 6 months. Calorie and fat intake were lower in the CR+G arm at 3 months (p's ≤ 0.05) but not at 6 months (p's > 0.20). CONCLUSIONS: Providing patients with genetic test results was not more effective in changing patient behavior to reduce the risk of DM compared to conventional risk counseling. TRIAL REGISTRATION: ClinicalTrials.gov NCT01060540 http://clinicaltrials.gov/show/NCT01060540.
RCT Entities:
OBJECTIVE: We examined the clinical utility of supplementing type 2 diabetes mellitus (DM) risk counseling with DM genetic test results and counseling. RESEARCH DESIGN AND METHODS: In this randomized controlled trial, non-diabetic overweight/obese veteran outpatients aged 21 to 65 years received DM risk estimates for lifetime risk, family history, and fasting plasma glucose, followed by either genetic test results (CR+G; N = 303) or control eye disease counseling (CR+EYE; N = 298). All participants received brief lifestyle counseling encouraging weight loss to reduce the risk of DM. RESULTS: The mean age was 54 years, 53% of participants were black, and 80% were men. There was no difference between arms in weight (estimated mean difference between CR+G vs. CR+EYE at 3 months = 0.2 kg, 95% CI: -0.3 to 0.7; at 6 months = 0.4 kg, 95 % CI: -0.3 to 1.1), insulin resistance, perceived risk, or physical activity at 3 or 6 months. Calorie and fat intake were lower in the CR+G arm at 3 months (p's ≤ 0.05) but not at 6 months (p's > 0.20). CONCLUSIONS: Providing patients with genetic test results was not more effective in changing patient behavior to reduce the risk of DM compared to conventional risk counseling. TRIAL REGISTRATION: ClinicalTrials.gov NCT01060540 http://clinicaltrials.gov/show/NCT01060540.
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