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BMC Psychiatry. 2012; 12: 95.
Published online Jul 30, 2012. doi:  10.1186/1471-244X-12-95
PMCID: PMC3495641
Effect of depression on mortality and cardiovascular morbidity in type 2 diabetes mellitus after 3 years follow up. The DIADEMA study protocol
Carmen de Burgos-Lunar,corresponding author1 Paloma Gómez-Campelo,2 Juan Cárdenas-Valladolid,3 Carmen Y Fuentes-Rodríguez,4 María I Granados-Menéndez,5 Francisco López-López,6 and Miguel A Salinero-Fort2, On behalf of the MADIABETES Group
1Unidad de Epidemiología Clínica e Investigación, Hospital Carlos III, (C/ Sinesio Delgado, 10), Madrid, (28029), Spain
2Fundación de Investigación Biomédica, Hospital Carlos III, (C/ Sinesio Delgado, 10), Madrid, (28029), Spain
3Unidad de Apoyo Técnico, Gerencia Adjunta de Planificación y Calidad del Servicio Madrileño de Salud, (C/ O’Donell, 55), Madrid, (28007), Spain
4Gerencia, Hospital Carlos III, (C/ Sinesio Delgado, 10), Madrid, (28029), Spain
5Centro de Salud Monóvar, Dirección Asistencial Este, Servicio Madrileño de Salud, Madrid, Spain
6Centro de Salud Vicente Muzas, Dirección Asistencial Este, Servicio Madrileño de Salud, Madrid, Spain
corresponding authorCorresponding author.
Carmen de Burgos-Lunar: carmenblunar/at/hotmail.com; Paloma Gómez-Campelo: pagocam/at/hotmail.com; Juan Cárdenas-Valladolid: jcardenas.gapm04/at/salud.madrid.org; Carmen Y Fuentes-Rodríguez: carmeny.fuentes/at/salud.madrid.org; María I Granados-Menéndez: igranados.gapm04/at/salud.madrid.org; Francisco López-López: lopezserna8/at/hotmail.com; Miguel A Salinero-Fort: miguel.salinero/at/salud.madrid.org
Received May 9, 2012; Accepted June 26, 2012.
Abstract
Background
Type 2 diabetes mellitus and depression are highly prevalent diseases that are associated with an increased risk of cardiovascular disease and mortality. There is evidence about a bidirectional association between depressive symptoms and type 2 diabetes mellitus. However, prognostic implications of the joint effects of these two diseases on cardiovascular morbidity and mortality are not well-known.
Method/design
A three-year, observational, prospective, cohort study, carried out in Primary Health Care Centres in Madrid (Spain). The project aims to analyze the effect of depression on cardiovascular events, all-cause and cardiovascular mortality in patients with type 2 diabetes mellitus, and to estimate a clinical predictive model of depression in these patients.
The number of patients required is 3255, all them with type 2 diabetes mellitus, older than 18 years, who regularly visit their Primary Health Care Centres and agree to participate. They are chosen by simple random sampling from the list of patients with type 2 diabetes mellitus of each general practitioner.
The main outcome measures are all-cause and cardiovascular mortality and cardiovascular morbidity; and exposure variable is the major depressive disorder.
There will be a comparison between depressed and not depressed patients in all-cause mortality, cardiovascular mortality, coronary artery disease and stroke using the Chi-squared test. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors that might alter the effect recorded will be taken into account in this analysis. To assess the effect of depression on the mortality, a survival analysis will be used comparing the two groups using the log-rank test. The control of potential confounding variables will be performed by the construction of a Cox regression model.
Discussion
Our study’s main contribution is to evaluate the increase in the risk of cardiovascular morbidity and mortality, in depressed Spanish adults with type 2 diabetes mellitus attended in Primary Health Care Setting. It would also be useful to identify subgroups of patients for which the interventions could be more beneficial.
Keywords: Depression, Diabetes mellitus, Type 2, Primary health care
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