Screening for type 2 diabetes in a high-risk population: study design and feasibility of a population-based randomized controlled trial

BMC Public Health

Harry J de Koning²  Jan J Lous³  Yolanda van der Graaf¹  Robert J Heine⁴  Suzie J Otto²  Bart Klijs² 

[1] Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht, Netherlands;Department of Public Health, Erasmus MC, P.O. Box 2040, 3000 CA, Rotterdam, Netherlands;Star-Medical Diagnostic Center, Rotterdam, Netherlands;EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, Netherlands and Eli-Lilly, Indianapolis, IN, USA

关键词: Waist circumference;    Abdominal obesity;    Type 2 diabetes;    Screening;    Early detection;   

Others  :  1163259
DOI  :  10.1186/1471-2458-12-671

 received in 2011-11-07, accepted in 2012-08-08,  发布年份 2012

【 摘 要 】

Background

We describe the design and present the results of the first year of a population-based study of screening for type 2 diabetes in individuals at high risk of developing the disease. High risk is defined as having abdominal obesity.

Methods

Between 2006 and 2007, 79,142 inhabitants of two Dutch municipalities aged 40–74 years were approached to participate in screening. Eligible participants had a self-reported waist circumference of ≥80 cm for women and ≥94 cm for men, and no known pre-existing diabetes. Of the respondents (n = 20,578; response rate 26%), 16,135 were abdominally obese. In total, 10,609 individuals gave written informed consent for participation and were randomized into either the screening (n = 5305) or the control arm (n = 5304). Participants in the screening arm were invited to have their fasting plasma glucose (FPG) measured and were referred to their general practitioner (GP) if it was ≥6.1 mmol/L. In addition, blood lipids were determined in the screening arm, because abdominal obesity is often associated with cardiovascular risk factors. Participants in both arms received written healthy lifestyle information. Between-group differences were analyzed with Chi-square tests and logistic regression (categorical variables) and unpaired t-tests (continuous variables).

Results

The screening attendance rate was 84.1%. Attending screening was associated with age at randomization (OR = 1.03, 95% CI 1.02-1.04), being married (OR = 1.57, 95% CI 1.33-1.83) and not-smoking currently (OR = 0.52, 95% CI 0.44-0.62). Of the individuals screened, 5.6% had hyperglycemia, and a further 11.6% had an estimated absolute cardiovascular disease risk of 5% or higher, according to the Systematic Coronary Risk Evaluation risk model. These participants were referred to their GP.

Conclusions

Self-reported home-assessed waist circumference could feasibly detect persons at high risk of hyperglycemia or cardiovascular disease. Continuation of the large-scale RCT is warranted to test the hypothesis that targeted population-based screening for type 2 diabetes leads to a significant reduction in cardiovascular morbidity and mortality.

Trial registration

ISRCTN75983009

【 授权许可】

   
2012 Klijs et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

【 参考文献 】

• [1]Shaw JE, Sicree RA, Zimmet PZ: Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract 2010, 87(1):4-14.
• [2]Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR: Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000, 321(7258):405-412.
• [3]Roper NA, Bilous RW, Kelly WF, Unwin NC, Connolly VM: Cause-specific mortality in a population with diabetes: South Tees Diabetes mortality study. Diabetes Care 2002, 25(1):43-48.
• [4]Barr EL, Zimmet PZ, Welborn TA, Jolley D, Magliano DJ, Dunstan DW, Cameron AJ, Dwyer T, Taylor HR, Tonkin AM, et al.: Risk of cardiovascular and all-cause mortality in individuals with diabetes mellitus, impaired fasting glucose, and impaired glucose tolerance: the Australian Diabetes, Obesity, and Lifestyle Study (AusDiab). Circulation 2007, 116(2):151-157.
• [5]World Health Organization: Screening for Type 2 Diabetes - Report of a World Health Organization and International Diabetes Federation meeting. Geneva: WHO - Department of Noncommunicable Disease Management; 2003.
• [6]Health Council of the Netherlands: Screening for type 2 diabetes. The Hague: Health Council of the Netherlands; 2004.
• [7]American Diabetes A: Standards of medical care in diabetes--2007. Diabetes Care 2007, 30 Suppl 1:S4-S41.
• [8]Alberti KG, Zimmet P, Shaw J: International Diabetes Federation: a consensus on Type 2 diabetes prevention. Diabet Med 2007, 24(5):451-463.
• [9]Waugh N, Scotland G, McNamee P, Gillett M, Brennan A, Goyder E, Williams R, John A: Screening for type 2 diabetes: literature review and economic modelling. Health Technol Assess 2007, 11(17):1-125. iii-iv, ix-xi
• [10]Norris SL, Kansagara D, Bougatsos C, Fu R, Force USPST: Screening adults for type 2 diabetes: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med 2008, 148(11):855-868.
• [11]Wilson JM, Jungner YG: Principles and practice of mass screening for disease. In Public Health Papers No 34. Geneva: World Health Organization; 1968:1-163.
• [12]Sheehy AM, Coursin DB, Gabbay RA: Back to Wilson and Jungner: 10 good reasons to screen for type 2 diabetes mellitus. Mayo Clin Proc 2009, 84(1):38-42.
• [13]Simmons RK, Echouffo-Tcheugui JB, Griffin SJ: Screening for type 2 diabetes: an update of the evidence. Diabetes Obes Metab 2010, 12(10):838-844.
• [14]Harris MI, Klein R, Welborn TA, Knuiman MW: Onset of NIDDM occurs at least 4–7 yr before clinical diagnosis. Diabetes Care 1992, 15(7):815-819.
• [15]Ryden L, Standl E, Bartnik M, Van den Berghe G, Betteridge J, de Boer MJ, Cosentino F, Jonsson B, Laakso M, Malmberg K, et al.: Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J 2007, 28(1):88-136.
• [16]Griffin SJ, Borch-Johnsen K, Davies MJ, Khunti K, Rutten GE, Sandbaek A, Sharp SJ, Simmons RK, van den Donk M, Wareham NJ, et al.: Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial. Lancet 2011, 378(9786):156-167.
• [17]Bemelmans WJE, Hoogenveen RT, Visscher TLS, Verschuren WMM, Schuit AJ: Toekomstige ontwikkelingen in overgewicht. Inschatting effecten op de volksgezondheid. Bilthoven: RIVM; 2004.
• [18]Carey VJ, Walters EE, Colditz GA, Solomon CG, Willett WC, Rosner BA, Speizer FE, Manson JE: Body fat distribution and risk of non-insulin-dependent diabetes mellitus in women. The nurses' health study. Am J Epidemiol 1997, 145(7):614-619.
• [19]Snijder MB, Dekker JM, Visser M, Bouter LM, Stehouwer CD, Kostense PJ, Yudkin JS, Heine RJ, Nijpels G, Seidell JC: Associations of hip and thigh circumferences independent of waist circumference with the incidence of type 2 diabetes: the Hoorn Study. Am J Clin Nutr 2003, 77(5):1192-1197.
• [20]Snijder MB, Zimmet PZ, Visser M, Dekker JM, Seidell JC, Shaw JE: Independent and opposite associations of waist and hip circumferences with diabetes, hypertension and dyslipidemia: the AusDiab Study. Int J Obes Relat Metab Disord 2004, 28(3):402-409.
• [21]Schulze MB, Heidemann C, Schienkiewitz A, Bergmann MM, Hoffmann K, Boeing H: Comparison of anthropometric characteristics in predicting the incidence of type 2 diabetes in the EPIC-Potsdam study. Diabetes Care 2006, 29(8):1921-1923.
• [22]Rutten GEHM, de Grauw WJC, Nijpels G, Goudswaard AN, Uitewaal PJM, van der Does FEE, Heine RJ, van Ballegooie E, Verduijn MM, Bouma M: NHG-Standaard Diabetes mellitus type 2 M01. NHG: In NHG-Standaarden; 2006.
• [23]Friedewald WT, Levy RI, Fredrickson DS: Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 1972, 18(6):499-502.
• [24]Conroy RM, Pyorala K, Fitzgerald AP, Sans S, Menotti A, De Backer G, De Bacquer D, Ducimetiere P, Jousilahti P, Keil U, et al.: Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur Heart J 2003, 24(11):987-1003.
• [25]Otto SJ, van der Cruijsen IW, Liem MK, Korfage IJ, Lous JJ, Schröder FH, de Koning HJ: Effective PSA contamination in the Rotterdam section of the European randomized study of screening for prostate cancer. Int J Cancer 2003, 105(3):394-399.
• [26]Lean ME, Han TS, Seidell JC: Impairment of health and quality of life in people with large waist circumference. Lancet 1998, 351(9106):853-856.
• [27]Baan CA, Nusselder WJ, Barendregt JJ, Ruwaard D, Bonneux L, Feskens EJ: The burden of mortality of diabetes mellitus in The Netherlands. Epidemiology 1999, 10(2):184-187.
• [28]de Koning HJ: Testing at home–the screening of the future? Eur J Public Health 2009, 19(1):5-6.
• [29]van den Donk M, Bobbink IW, Gorter KJ, Salome PL, Rutten GE: Identifying people with metabolic syndrome in primary care by screening with a mailed tape measure. A survey in 14,000 people in the Netherlands. Prev Med 2009, 48(4):345-50.
• [30]Korhonen PE, Jaatinen PT, Aarnio PT, Kantola IM, Saaresranta T: Waist circumference home measurement–a device to find out patients in cardiovascular risk. Eur J Public Health 2009, 19(1):95-99.
• [31]Janssen PG, Gorter KJ, Stolk RP, Rutten GE: Low yield of population-based screening for Type 2 diabetes in the Netherlands: the ADDITION Netherlands study. Fam Pract 2007, 24(6):555-561.
• [32]Ruige JB, de Neeling JN, Kostense PJ, Bouter LM, Heine RJ: Performance of an NIDDM screening questionnaire based on symptoms and risk factors. Diabetes Care 1997, 20(4):491-496.
• [33]Spijkerman AM, Dekker JM, Nijpels G, Jager A, Kostense PJ, van Hinsbergh VW, Bouter LM, Heine RJ, Stehouwer CD: Impact of diabetes duration and cardiovascular risk factors on mortality in type 2 diabetes: the Hoorn Study. Eur J Clin Invest 2002, 32(12):924-930.
• [34]van 't Riet E, Alssema M, Rijkelijkhuizen JM, Kostense PJ, Nijpels G, Dekker JM: Relationship between A1C and glucose levels in the general Dutch population: the new Hoorn study. Diabetes Care 2010, 33(1):61-66.
• [35]de Koning HJ, de Ridder-Sluiter JG, Van Agt HM, Reep-Van Den Bergh CM, Van Der Stege HA, Korfage IJ, Polder JJ, Van Der Maas PJ: A cluster-randomised trial of screening for language disorders in toddlers. J Med Screen 2004, 11(3):109-116.
• [36]Roobol MJ, Kirkels WJ, Schroder FH: Features and preliminary results of the Dutch centre of the ERSPC (Rotterdam, the Netherlands). BJU Int 2003, 92(Suppl 2):48-54.
• [37]van Iersel CA, de Koning HJ, Draisma G, Mali WP, Scholten ET, Nackaerts K, Prokop M, Habbema JD, Oudkerk M, van Klaveren RJ: Risk-based selection from the general population in a screening trial: selection criteria, recruitment and power for the Dutch-Belgian randomised lung cancer multi-slice CT screening trial (NELSON). Int J Cancer 2007, 120(4):868-874.
• [38]Council of Europe: Common European Framework of Reference for Languages: Learning, Teaching, Assessment. Camebridge, UK: Camebridge University Press; 2001.
• [39]Schwarz PE, Li J, Lindstrom J, Tuomilehto J: Tools for predicting the risk of type 2 diabetes in daily practice. Horm Metab Res 2009, 41(2):86-97.
• [40]Chamnan P, Simmons RK, Khaw KT, NJ Wa, Griffin S: Estimating the potential population impact of stepwise screening strategies for identifying and treating individuals at high risk of Type 2 diabetes: a modelling study. Diabet Med 2012, 29(7):893-904.