The Effects of a Mediterranean Diet on the Need for Diabetes Drugs and Remission of Newly Diagnosed Type 2 Diabetes: Follow-up of a Randomized Trial

Abstract

OBJECTIVETo assess the long-term effects of dietary interventions on glycemic control, need for diabetes medications, and remission of type 2 diabetes. RESEARCH DESIGN AND METHODSOriginally, in a two-arm trial design, overweight, middle-aged men and women with newly diagnosed type 2 diabetes were randomized to a low-carbohydrate Mediterranean diet (LCMD; n = 108) or a low-fat diet (n = 107). After 4 years, participants who were still free of diabetes medications were further followed up until the primary end point (need of a diabetic drug); remission of diabetes (partial or complete) and changes in weight, glycemic control, and cardiovascular risk factors were also evaluated. RESULTSThe primary end point was reached in all participants after a total follow-up of 6.1 years in the low-fat group and 8.1 years in the LCMD group; median survival time was 2.8 years (95% CI 2.4-3.2) and 4.8 years (4.3-5.2), respectively. The unadjusted hazard ratio for the overall follow-up was 0.68 (0.50-0.89; P < 0.001). LCMD participants were more likely to experience any remission (partial or complete), with a prevalence of 14.7% (13.0-16.5%) during the first year and 5.0% (4.4-5.6%) during year 6 compared with 4.1% (3.1-5.0%) at year 1 and 0% at year 6 in the low-fat diet group. CONCLUSIONSIn patients with newly diagnosed type 2 diabetes, an LCMD resulted in a greater reduction of HbA 1c levels, higher rate of diabetes remission, and delayed need for diabetes medication compared with a low-fat diet.Type 2 diabetes is now pandemic and shows no signs of abatement. The estimated worldwide prevalence of diabetes among adults aged 20-79 years was 366 million (8.3%) in 2011, and this value is predicted to rise to ;562 million (9.9%) by 2030 (1). This increase in type 2 diabetes is inextricably linked to changes toward a Western lifestyle (high-energy diets with reduced physical activity) in developing countries and the rise in the prevalence of overweight and obesity (2). Nutritional epidemiology has established the associations of overall dietary patterns with diabetes risk

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“…An extensive metaanalysis including 136,846 participants indicated that a higher adherence to MD was associated with 23 % reduced risk of developing type 2 diabetes (11). In patients with newly diagnosed type 2 diabetes, consumption of MD resulted in a greater reduction of HbA1c levels, higher rate of diabetes remission, and delayed need for diabetes medication, compared to a less specifi c low-fat diet (12). MD enriched with extra-virgin olive oil but without energy restrictions reduced diabetes risk among persons with a high cardiovascular risk (13).…”

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“…In addition, randomized controlled intervention studies have revealed that it is effective in the primary prevention of cardiovascular diseases [45], in improving diabetes [46] and cognitive function [47], and recently also in the primary prevention of invasive breast cancer [48]. …”

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“…Esposito et al performed a two-armed randomized controlled trial to assess the impact of dietary intervention, such as Mediterranean-style diets (Med diets), on the need for anti-hyperglycemic drug therapy and remission of T2DM in those newly diagnosed [9]. The study included 215 men and women who were middle-aged (mean age 52.2 years) and overweight (mean BMI 29.6 kg/m 2 ), were newly diagnosed with T2DM and had never received anti-hyperglycemic medications.…”