Opportunistic Screening for Prediabetes and Early Diabetes in Primary Care
NCT ID: NCT00787839
Last Updated: 2015-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
1939 participants
OBSERVATIONAL
2009-06-30
2012-12-31
Brief Summary
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Detailed Description
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BACKGROUND: Prediabetes is a major public health problem which confers risk of diabetes and cardiovascular disease (CVD), but veterans with prediabetes are not detected, and cannot receive interventions to reduce their risks; CVD events, health resource use, and cost all rise before diabetes is diagnosed. Diabetes can be prevented or delayed by lifestyle change or medication, but since we do not identify prediabetes, glucose intolerance progresses for 5-10 years, and many patients have early diabetes complications and increased CVD risk when they are finally recognized. We are developing a new screening test for prediabetes, a "glucose challenge test" (GCT): patients have a 50g oral glucose challenge at any time of day, regardless of meal status, with a single 1 hr sample. If the GCT exceeds a cutoff, they have a 75g oral glucose tolerance test after an overnight fast, with 0 and 2 hr samples (OGTT). Our GCRC-based Preliminary Data show ROC AUC 0.83 (70% specificity, 82% sensitivity) and $51 per case identified; the GCT should constitute an effective, convenient, inexpensive, cost-effective screen for prediabetes - a critical indicator of individual, VA health care system, and societal risk.
OBJECTIVES: To translate our findings into improved health for VA patients, the GCT will need to be implemented in VA primary care settings - where practitioners often do not screen for prediabetes, or manage diabetes optimally. Such barriers must be overcome in order to conduct definitive studies aimed to show that use of the GCT to detect prediabetes (and previously unrecognized diabetes) in primary care leads to improved outcomes. Thus, VA policies for system-wide implementation of GCT screening must be preceded by logical next steps: validation and demonstration of likely cost-effectiveness.
METHODS: AIM #1. Validation: (A) To establish feasibility, we will interact with VA primary care providers to solve logistical problems, and determine optimal screening strategies. (B) To assess test performance, we will (a) perform GCTs and measure A1c in \~1,800 patients, (b) evaluate OGTTs in all subjects, and (c) compare sensitivity, specificity, and ROC curves from GCT vs. A1c or "predictive model" screening in primary care to those in our GCRC studies. Availability of this dataset will also permit (d) subsequent management of diabetes/prediabetes to be evaluated relative to standardized guidelines. AIM #2. Costs: To evaluate impact, we will (a) capture the costs of diagnostic tests, staff effort, and patient time; (b) express cost per case identified from both VA health system and societal perspectives; and (c) compare GCT vs. alternative strategies with a wide range of assumptions about false-(+)/false-(-) costs to reflect downstream cost implications of test imperfections. Engagement with this process will also provide (d) for those study patients with prediabetes who go on to develop diabetes, an opportunity to explore VA resource use and costs before and after the diagnosis of diabetes. This will provide preliminary data for subsequent proposals to compare resource use and costs vs. those of other VA patients who are newly diagnosed with diabetes in settings where there is no screening for prediabetes.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Group 1
Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, the American Diabetes Association, and the National Institutes of Health
Glucose challenge test
At a first outpatient visit, at different times of the day and without a prior fast, subjects will have a 50 gram glucose drink followed by measurement of plasma and capillary glucose along with A1c one hour later. They will also fill out questionnaires. At a second outpatient visit, in the morning after fasting overnight, they will have a 75 gram oral glucose tolerance test.
Glucose tolerance test
Subjects found to have diabetes or prediabetes on the initial glucose tolerance test may be requested to have a repeat glucose tolerance test and A1c.
Interventions
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Glucose challenge test
At a first outpatient visit, at different times of the day and without a prior fast, subjects will have a 50 gram glucose drink followed by measurement of plasma and capillary glucose along with A1c one hour later. They will also fill out questionnaires. At a second outpatient visit, in the morning after fasting overnight, they will have a 75 gram oral glucose tolerance test.
Glucose tolerance test
Subjects found to have diabetes or prediabetes on the initial glucose tolerance test may be requested to have a repeat glucose tolerance test and A1c.
Eligibility Criteria
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Inclusion Criteria
* ambulatory outpatient at Atlanta VA Medical Center,
* visit to primary care clinic, AND
* meet criteria for screening (age \>= 45 years or other risk factors \[body mass index \>=25 or hypertension or systolic blood pressure \>=140 or HDL cholesterol \<35 in men or \<45 in women or fasting triglycerides \>250 or first-degree relative with diabetes or minority race or minority ethnicity or history of diabetes during pregnancy or history of having a baby weighing \>9 pounds or history of polycystic ovary syndrome\])
Exclusion Criteria
* taking steroids OR pregnant, OR
* not well enough to have worked during the previous week (actual employment not necessary)
18 Years
ALL
Yes
Sponsors
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Emory University
OTHER
US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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Lawrence S Phillips, MD
Role: PRINCIPAL_INVESTIGATOR
Atlanta VA Medical and Rehab Center, Decatur, GA
Locations
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Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States
Countries
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References
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Twombly JG, Long Q, Zhu M, Wilson PW, Narayan KM, Fraser LA, Webber BC, Phillips LS. Diabetes care in black and white veterans in the southeastern U.S. Diabetes Care. 2010 May;33(5):958-63. doi: 10.2337/dc09-1556. Epub 2010 Jan 26.
Ziemer DC, Kolm P, Weintraub WS, Vaccarino V, Rhee MK, Twombly JG, Narayan KM, Koch DD, Phillips LS. Glucose-independent, black-white differences in hemoglobin A1c levels: a cross-sectional analysis of 2 studies. Ann Intern Med. 2010 Jun 15;152(12):770-7. doi: 10.7326/0003-4819-152-12-201006150-00004.
Rhee MK, Herrick K, Ziemer DC, Vaccarino V, Weintraub WS, Narayan KM, Kolm P, Twombly JG, Phillips LS. Many Americans have pre-diabetes and should be considered for metformin therapy. Diabetes Care. 2010 Jan;33(1):49-54. doi: 10.2337/dc09-0341. Epub 2009 Oct 6.
Olson DE, Rhee MK, Herrick K, Ziemer DC, Twombly JG, Phillips LS. Screening for diabetes and pre-diabetes with proposed A1C-based diagnostic criteria. Diabetes Care. 2010 Oct;33(10):2184-9. doi: 10.2337/dc10-0433. Epub 2010 Jul 16.
Fraser LA, Twombly J, Zhu M, Long Q, Hanfelt JJ, Narayan KM, Wilson PW, Phillips LS. Delay in diagnosis of diabetes is not the patient's fault. Diabetes Care. 2010 Jan;33(1):e10. doi: 10.2337/dc09-1129. No abstract available.
Lin E, Liang Z, Frediani J, Davis SS Jr, Sweeney JF, Ziegler TR, Phillips LS, Gletsu-Miller N. Improvement in ss-cell function in patients with normal and hyperglycemia following Roux-en-Y gastric bypass surgery. Am J Physiol Endocrinol Metab. 2010 Nov;299(5):E706-12. doi: 10.1152/ajpendo.00405.2010. Epub 2010 Aug 17.
Chatterjee R, Narayan KM, Lipscomb J, Phillips LS. Screening adults for pre-diabetes and diabetes may be cost-saving. Diabetes Care. 2010 Jul;33(7):1484-90. doi: 10.2337/dc10-0054.
Twombly JG, Long Q, Zhu M, Fraser LA, Olson DE, Wilson PW, Narayan KM, Phillips LS. Validity of the primary care diagnosis of diabetes in veterans in the southeastern United States. Diabetes Res Clin Pract. 2011 Mar;91(3):395-400. doi: 10.1016/j.diabres.2010.11.001. Epub 2010 Nov 26.
Phillips LS, Ziemer DC, Kolm P, Weintraub WS, Vaccarino V, Rhee MK, Chatterjee R, Narayan KM, Koch DD. Glucose challenge test screening for prediabetes and undiagnosed diabetes. Diabetologia. 2009 Sep;52(9):1798-807. doi: 10.1007/s00125-009-1407-7. Epub 2009 Jun 26.
Shikany JM, Tinker LF, Neuhouser ML, Ma Y, Patterson RE, Phillips LS, Liu S, Redden DT. Association of glycemic load with cardiovascular disease risk factors: the Women's Health Initiative Observational Study. Nutrition. 2010 Jun;26(6):641-7. doi: 10.1016/j.nut.2009.08.014. Epub 2010 Jan 6.
Buse JB. Screening for diabetes and prediabetes with proposed A1C-based diagnostic criteria: comment on Olson et al. Diabetes Care. 2010 Dec;33(12):e174; author reply e175. doi: 10.2337/dc10-1720. No abstract available.
Margolis KL, Wei F, de Boer IH, Howard BV, Liu S, Manson JE, Mossavar-Rahmani Y, Phillips LS, Shikany JM, Tinker LF; Women's Health Initiative Investigators. A diet high in low-fat dairy products lowers diabetes risk in postmenopausal women. J Nutr. 2011 Nov;141(11):1969-74. doi: 10.3945/jn.111.143339. Epub 2011 Sep 21.
Tinker LF, Sarto GE, Howard BV, Huang Y, Neuhouser ML, Mossavar-Rahmani Y, Beasley JM, Margolis KL, Eaton CB, Phillips LS, Prentice RL. Biomarker-calibrated dietary energy and protein intake associations with diabetes risk among postmenopausal women from the Women's Health Initiative. Am J Clin Nutr. 2011 Dec;94(6):1600-6. doi: 10.3945/ajcn.111.018648. Epub 2011 Nov 9.
Chlebowski RT, McTiernan A, Wactawski-Wende J, Manson JE, Aragaki AK, Rohan T, Ipp E, Kaklamani VG, Vitolins M, Wallace R, Gunter M, Phillips LS, Strickler H, Margolis K, Euhus DM. Diabetes, metformin, and breast cancer in postmenopausal women. J Clin Oncol. 2012 Aug 10;30(23):2844-52. doi: 10.1200/JCO.2011.39.7505. Epub 2012 Jun 11.
Ma Y, Hebert JR, Manson JE, Balasubramanian R, Liu S, Lamonte MJ, Bird CE, Ockene JK, Qiao Y, Olendzki B, Schneider KL, Rosal MC, Sepavich DM, Wactawski-Wende J, Stefanick ML, Phillips LS, Ockene IS, Kaplan RC, Sarto GE, Garcia L, Howard BV. Determinants of racial/ethnic disparities in incidence of diabetes in postmenopausal women in the U.S.: The Women's Health Initiative 1993-2009. Diabetes Care. 2012 Nov;35(11):2226-34. doi: 10.2337/dc12-0412. Epub 2012 Jul 25.
You NC, Chen BH, Song Y, Lu X, Chen Y, Manson JE, Kang M, Howard BV, Margolis KL, Curb JD, Phillips LS, Stefanick ML, Tinker LF, Liu S. A prospective study of leukocyte telomere length and risk of type 2 diabetes in postmenopausal women. Diabetes. 2012 Nov;61(11):2998-3004. doi: 10.2337/db12-0241. Epub 2012 Jul 24.
Gletsu-Miller N, Kahn HS, Gasevic D, Liang Z, Frediani JK, Torres WE, Ziegler TR, Phillips LS, Lin E. Sagittal abdominal diameter and visceral adiposity: correlates of beta-cell function and dysglycemia in severely obese women. Obes Surg. 2013 Jul;23(7):874-81. doi: 10.1007/s11695-013-0874-6.
Phillips LS, Olson DE. Diabetes: normal glucose levels should be the goal. Nat Rev Endocrinol. 2012 Sep;8(9):510-2. doi: 10.1038/nrendo.2012.139. Epub 2012 Jul 31. No abstract available.
Other Identifiers
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IIR 07-138
Identifier Type: -
Identifier Source: org_study_id
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