Effects of a Mediterranean-Style Diet on the Need for Antihyperglycemic Drug Therapy in Patients With Newly Diagnosed Type 2 Diabetes
A Randomized Trial
- 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; and
- Dario Giugliano, MD, PhD
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 A1c (HbA1c) 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 HbA1c 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.
Article and Author Information
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Grant Support: In part by the Second University of Naples.
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Potential Financial Conflicts of Interest: None disclosed.
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Reproducible Research Statement: Study protocol and data set: Not available. Statistical code: Available from Dr. Giugliano (e-mail, dario.giugliano{at}unina2.it).
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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, dario.giugliano{at}unina2.it.
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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.
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Dr. Beneduce: Division of Internal Medicine, ASLNA5, Vico Equense/Sorrento, Naples, Italy.
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Dr. Ceriello: Warwick Medical School, Clinical Science Research Institute, Clinical Science Building, University Hospital, Walsgrave Campus, Clifford Bridge Road, Coventry CV2 2VX, United Kingdom.
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Author Contributions: Conception and design: K. Esposito, D. Giugliano.
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Analysis and interpretation of the data: K. Esposito, C. Di Palo, F. Beneduce, A. Ceriello, D. Giugliano.
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Drafting of the article: K. Esposito, A. Ceriello, D. Giugliano.
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Critical revision of the article for important intellectual content: K. Esposito, M.I. Maiorino, M. Ciotola, A. Ceriello, D. Giugliano.
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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.
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Provision of study materials or patients: M.I. Maiorino, M. Ciotola, C. Di Palo, P. Scognamiglio, M. Gicchino, M. Petrizzo, F. Saccomanno, F. Beneduce.
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Statistical expertise: K. Esposito, D. Giugliano.
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Obtaining of funding: K. Esposito, M.I. Maiorino, M. Ciotola, M. Gicchino, F. Saccomanno, D. Giugliano.
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Administrative, technical, or logistic support: M.I. Maiorino, M. Ciotola, P. Scognamiglio, M. Petrizzo, F. Saccomanno, F. Beneduce, D. Giugliano.
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Collection and assembly of data: K. Esposito, M.I. Maiorino, M. Ciotola, C. Di Palo, P. Scognamiglio, M. Gicchino, M. Petrizzo, F. Beneduce.
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ClinicalTrials.gov identification number: NCT00725257.
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