title: Effects of a Mediterranean-style diet on the need for antihyperglycemic drug therapy in patients with newly diagnosed type 2 diabetes: a randomized trial.
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.
  
  
  METHODS
  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.
  
  
  METHODS
  Teaching hospital in Naples, Italy.
  
  
  METHODS
  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%.
  
  
  METHODS
  Mediterranean-style diet (<50% of daily calories from carbohydrates) (n = 108) or a low-fat diet (<30% of daily calories from fat) (n = 107).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Investigators responsible for initiating drug therapy were not blinded to treatment assignment. Dietary intake was self-reported.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Second University of Naples.
authors.affiliation: Second University of Naples and ASLNA5, Vico Equense/Sorrento, Naples, Italy.
authors.forename: Katherine
authors.initials: K
authors.lastname: Esposito
authors.forename: Maria Ida
authors.initials: MI
authors.lastname: Maiorino
authors.forename: Miryam
authors.initials: M
authors.lastname: Ciotola
authors.forename: Carmen
authors.initials: C
authors.lastname: Di Palo
authors.forename: Paola
authors.initials: P
authors.lastname: Scognamiglio
authors.forename: Maurizio
authors.initials: M
authors.lastname: Gicchino
authors.forename: Michela
authors.initials: M
authors.lastname: Petrizzo
authors.forename: Franco
authors.initials: F
authors.lastname: Saccomanno
authors.forename: Flora
authors.initials: F
authors.lastname: Beneduce
authors.forename: Antonio
authors.initials: A
authors.lastname: Ceriello
authors.forename: Dario
authors.initials: D
authors.lastname: Giugliano
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000178:diet therapy* / Q000188:drug therapy; D050528:Diet, Carbohydrate-Restricted; D018752:Diet, Fat-Restricted; D038441:Diet, Mediterranean; D015444:Exercise; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000178:diet therapy; D050177:Overweight / Q000150:complications / Q000178:diet therapy*; D012307:Risk Factors; D015431:Weight Loss
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents