Effects of a Mediterranean-style diet on the need for antihyperglycemic drug therapy in patients with newly diagnosed type 2 diabetes: a randomized trial.
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.
Esposito
Katherine
K
Second University of Naples and ASLNA5, Vico Equense/Sorrento, Naples, Italy.
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
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
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents