Effects of a Mediterranean-style diet on the need for antihyperglycemic drug therapy in patients with newly diagnosed type 2 diabetes: a randomized trial.

Full Abstract

BACKGROUND: Low-carbohydrate and low-fat calorie-restricted diets are recommended for weight loss in overweight and obese people with type 2 diabetes. OBJECTIVE: To compare the effects of a low-carbohydrate Mediterranean-style or a low-fat diet on the need for antihyperglycemic drug therapy in patients with newly diagnosed type 2 diabetes. DESIGN: Single-center, randomized trial. Randomization was computer-generated and unstratified. Allocation was concealed in sealed study folders held in a central, secure location until participants gave informed consent. Participants and investigators were aware of treatment assignment, and assessors of the primary outcome were blinded. SETTING: Teaching hospital in Naples, Italy. PATIENTS: 215 overweight people with newly diagnosed type 2 diabetes who were never treated with antihyperglycemic drugs and had hemoglobin A(1c) (HbA(1c)) levels less than 11%. INTERVENTION: Mediterranean-style diet (<50% of daily calories from carbohydrates) (n = 108) or a low-fat diet (<30% of daily calories from fat) (n = 107). MEASUREMENTS: Start of antihyperglycemic drug therapy, defined by protocol as indicated for follow-up HbA(1c) level greater than 7% (primary outcome), and changes in weight, glycemic control, and coronary risk factors (secondary outcomes). RESULTS: After 4 years, 44% of patients in the Mediterranean-style diet group and 70% in the low-fat diet group required treatment (absolute difference, -26.0 percentage points [95% CI, -31.1 to -20.1 percentage points]; hazard ratio, 0.63 [CI, 0.51 to 0.86]; hazard ratio adjusted for weight change, 0.70 [CI, 0.59 to 0.90]; P < 0.001). Participants assigned to the Mediterranean-style diet lost more weight and experienced greater improvements in some glycemic control and coronary risk measures than did those assigned to the low-fat diet. LIMITATIONS: Investigators responsible for initiating drug therapy were not blinded to treatment assignment. Dietary intake was self-reported. CONCLUSION: Compared with a low-fat diet, a low-carbohydrate, Mediterranean-style diet led to more favorable changes in glycemic control and coronary risk factors and delayed the need for antihyperglycemic drug therapy in overweight patients with newly diagnosed type 2 diabetes. PRIMARY FUNDING SOURCE: Second University of Naples.

Author information

Author/s: Esposito, Katherine (K); Maiorino, Maria Ida (MI); Ciotola, Miryam (M); Di Palo, Carmen (C); Scognamiglio, Paola (P); Gicchino, Maurizio (M); Petrizzo, Michela (M); Saccomanno, Franco (F); Beneduce, Flora (F); Ceriello, Antonio (A); Giugliano, Dario (D);

Affiliation: Second University of Naples and ASLNA5, Vico Equense/Sorrento, Naples, Italy.

Journal and publication information

Publication Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: Annals of internal medicine (Ann Intern Med), published in United States. (Language: eng)

Reference: 2009-Sep; vol 151 (issue 5) : pp 306-14

Dates: Created 2009/09/01; Completed 2009/09/21; Revised 2009/11/05;

PMID: 19721018, status: MEDLINE (last retrieval date: 11/5/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

Comments and Corrections

ErratumIn: Ann Intern Med. 2009 Oct 20;151(8):591.

SummaryForPatientsIn: Ann Intern Med. 2009 Sep 1;151(5):I42. (PMID: 19721015)

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