Journal of Diabetes and its Complications
Effects of Mediterranean diet on sexual function in people with newly diagnosed type 2 diabetes: The MÈDITA trial
Introduction
Type 2 diabetes is a prevalent chronic disease and shows no signs of abatement. According to the International Diabetes Federation, 415 million adults are estimated to currently have diabetes worldwide, with the alarming prediction of 642 million cases by the year 2040 (International Diabetes Federation, 2015). Vascular diabetic complications cause substantial human and economic burdens (Dall et al., 2014).
Type 2 diabetes has been associated with sexual dysfunction both in men (Penson et al., 2003) and in women (Pontiroli, Cortelazzi, & Morabito, 2013). A threefold increased risk of erectile dysfunction (ED) has been documented in diabetic men compared with nondiabetic men (Feldman, Goldstein, Hatzichristou, Krane, & McKinlay, 1994). Moreover, ED is a marker of significantly increased risk of cardiovascular disease (Dong, Zhang, & Qin, 2011) and all-cause mortality (Araujo et al., 2009); in a prospective study of 291 type 2 diabetic men with silent coronary artery disease (Gazzaruso et al., 2008), ED was associated with a twofold increase of cardiovascular morbidity and mortality after a mean follow-up of 47 months.
The association between diabetes and sexual dysfunction in women is less conclusive, although most studies have reported a higher prevalence of female sexual dysfunction (FSD) in diabetic women as compared with nondiabetic women (Miner, Esposito, Guay, Montorsi, & Goldstein, 2012). Some studies have reported an association between female sexual health and vascular risk factors, including type 2 diabetes, although no data support a clear role for FSD as a predictor of future cardiovascular events in diabetic women (Miner et al., 2012).
There is some evidence from clinical trials that sexual dysfunction is amenable to amelioration with interventions based on diet and lifestyle modification, both in men (Esposito et al., 2010, Esposito et al., 2004, Gupta et al., 2011) and in women (Esposito et al., 2007a, Wing et al., 2013). In the present study, we assessed male and female sexual function prospectively in participants in the MЀDITA trial. MЀDITA (MEditerranean DIet and Type 2 diAbetes) is a long-term randomized trial that demonstrated the superiority of Mediterranean diet, as compared with low-fat diet, in delaying need for diabetes medication in newly diagnosed type 2 diabetic subjects (Esposito et al., 2014, Esposito et al., 2009b).
Section snippets
Subjects
The MЀDITA trial was a single center, randomized, controlled trial aimed at prevention of diabetes drugs in type 2 diabetes by dietary intervention. The eligibility criteria for MЀDITA have been described elsewhere (Esposito et al., 2009b, Esposito et al., 2014). Briefly, participants were eligible for the trial if they had newly diagnosed type 2 diabetes never treated with antidiabetic drugs, age 30–75 years, body mass index (BMI) greater than 25 kg/m2, and hemoglobin A1c (HbA1c) level less than
Interventions
Originally, 215 men and women with newly diagnosed type 2 diabetes were randomized by using a computer-generated random-number sequence (simple randomization) at the baseline visit to one of two treatment diets, a Mediterranean diet (n = 108) or a low-fat diet (n = 107). The main goals of the dietary interventions were restriction of energy intake to 1500 kcal/day for women and 1800 kcal/day for men in both groups. The Mediterranean diet had the goal of no more than 50% of calories from carbohydrates
Baseline characteristics of participants
The present study comprised all the 215 participants who were eligible for the MЀDITA trial. The treatment groups were well matched for demographic and clinical characteristics (Table 1). The composition of the diets consumed by participants in the Mediterranean diet and low-fat diet groups was not different at baseline.
The baseline mean erectile function score was 21.9 in both groups of men assigned to the two treatment diets, with a similar distribution across the different categories of ED (
Discussion
The current study is the first long-term dietary trial to prospectively examine the effect of Mediterranean diet on sexual function in men and women with newly diagnosed type 2 diabetes. As compared with control low-fat diet, Mediterranean diet significantly delayed the deterioration of sexual function among high-risk persons who were initially free of sexual dysfunction. These results are to be viewed as conservative, because all participants in the low-fat group remained into the trial until
Acknowledgments
Funding/support: This study was supported in part by the Second University of Naples and the Associazione Salute con Stile.
Role of the funder/sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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Trial registration clinicaltrials.gov Identifier: NCT00725257.
Conflict of interest disclosures: Dr Esposito and Dr Giugliano reported receiving speaker fees from and serving on advisory boards for Merck Sharp & Dohme, Lilly, NOVO, and Sanofi. No other disclosures were reported.