Katherine Esposito, MD, PhD; Maria Ida Maiorino, MD; Miryam Ciotola, MD; Carmen Di Palo, MD; Paola Scognamiglio, MD; Maurizio Gicchino, MD; Michela Petrizzo, MD; Franco Saccomanno, MD; Flora Beneduce, MD; Antonio Ceriello, MD; Dario Giugliano, MD, PhD
Grant Support: In part by the Second University of Naples.
Potential Financial Conflicts of Interest: None disclosed.
Reproducible Research Statement:Study protocol and data set: Not available. Statistical code: Available from Dr. Giugliano (e-mail, email@example.com).
Requests for Single Reprints: Dario Giugliano, MD, PhD, Division of Metabolic Diseases, Azienda Ospedaliera Universitaria, Seconda Università di Napoli, Piazza L. Miraglia, 80138 Naples, Italy; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Esposito, Maiorino, Ciotola, Di Palo, Scognamiglio, Gicchino, Petrizzo, Saccomanno, and Giugliano: Department of Geriatrics and Metabolic Diseases, Second University of Naples, Piazza L. Miraglia 2, 80138 Naples, Italy.
Dr. Beneduce: Division of Internal Medicine, ASLNA5, Vico Equense/Sorrento, Naples, Italy.
Dr. Ceriello: Warwick Medical School, Clinical Science Research Institute, Clinical Science Building, University Hospital, Walsgrave Campus, Clifford Bridge Road, Coventry CV2 2VX, United Kingdom.
Author Contributions: Conception and design: K. Esposito, D. Giugliano.
Analysis and interpretation of the data: K. Esposito, C. Di Palo, F. Beneduce, A. Ceriello, D. Giugliano.
Drafting of the article: K. Esposito, A. Ceriello, D. Giugliano.
Critical revision of the article for important intellectual content: K. Esposito, M.I. Maiorino, M. Ciotola, A. Ceriello, D. Giugliano.
Final approval of the article: K. Esposito, M.I. Maiorino, M. Ciotola, C. Di Palo, P. Scognamiglio, M. Gicchino, M. Petrizzo, F. Saccomanno, F. Beneduce, A. Ceriello, D. Giugliano.
Provision of study materials or patients: M.I. Maiorino, M. Ciotola, C. Di Palo, P. Scognamiglio, M. Gicchino, M. Petrizzo, F. Saccomanno, F. Beneduce.
Statistical expertise: K. Esposito, D. Giugliano.
Obtaining of funding: K. Esposito, M.I. Maiorino, M. Ciotola, M. Gicchino, F. Saccomanno, D. Giugliano.
Administrative, technical, or logistic support: M.I. Maiorino, M. Ciotola, P. Scognamiglio, M. Petrizzo, F. Saccomanno, F. Beneduce, D. Giugliano.
Collection and assembly of data: K. Esposito, M.I. Maiorino, M. Ciotola, C. Di Palo, P. Scognamiglio, M. Gicchino, M. Petrizzo, F. Beneduce.
ClinicalTrials.gov identification number: NCT00725257.
Esposito K, Maiorino MI, Ciotola M, Di Palo C, Scognamiglio P, Gicchino M, et al. Effects of a Mediterranean-Style Diet on the Need for Antihyperglycemic Drug Therapy in Patients With Newly Diagnosed Type 2 Diabetes: A Randomized Trial. Ann Intern Med. 2009;151:306-314. doi: 10.7326/0003-4819-151-5-200909010-00004
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Published: Ann Intern Med. 2009;151(5):306-314.
Low-carbohydrate and low-fat calorie-restricted diets are recommended for weight loss in overweight and obese people with type 2 diabetes.
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.
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.
Teaching hospital in Naples, Italy.
215 overweight people with newly diagnosed type 2 diabetes who were never treated with antihyperglycemic drugs and had hemoglobin A1c (HbA1c) levels less than 11%.
Mediterranean-style diet (<50% of daily calories from carbohydrates) (nÂ = 108) or a low-fat diet (<30% of daily calories from fat) (nÂ = 107).
Start of antihyperglycemic drug therapy, defined by protocol as indicated for follow-up HbA1c level greater than 7% (primary outcome), and changes in weight, glycemic control, and coronary risk factors (secondary outcomes).
After 4 years, 44% of patients in the Mediterranean-style diet group and 70% in the low-fat diet group required treatment (absolute difference, âˆ’26.0 percentage points [95% CI, âˆ’31.1 to âˆ’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]; PÂ < 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.
Investigators responsible for initiating drug therapy were not blinded to treatment assignment. Dietary intake was self-reported.
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.
Second University of Naples.
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Cardiology, Endocrine and Metabolism, Diabetes, Coronary Risk Factors, Prevention/Screening.
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