Dietary Control of Type 2 Diabetes: Low-Carbohydrate Mediterranean Diet Versus Low-Fat Diet

University of Campania "Luigi Vanvitelli"

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Other: Low-fat diet

Other: Mediterranean diet

Study type

Interventional

Funder types

Other

Identifiers

NCT00725257

DGMM/4/2004

Details and patient eligibility

About

The major environmental factors that increase the risk of type 2 diabetes, presumably in the setting of genetic risk, are overnutrition and a sedentary lifestyle, with consequent overweight and obesity. The high rate of weight regain has limited the role of lifestyle interventions as an effective means of controlling glycemia long term. The aims of the present study were: 1) To compare the effectiveness and safety of two nutritional protocols - namely low-carbohydrate Mediterranean diet or low-fat diet - in newly-diagnosed, drug-naive overweight patients with type 2 diabetes mellitus. The primary aim of the study was the effect on hemoglobin A1c levels; secondary aims were time to introduction of the first hypoglycemic agent, prevalence of the metabolic syndrome, percentage of patients meeting ADA goals for risk factors (HbA1c, blood pressure, LDL-cholesterol, percentage of patients with HbA1c < 7%.

Enrollment

215 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 diabetes mellitus (ADA criteria)
BMI (body mass index) > 25 kg/M2
Hemoglobin A1c (HbA1c) < 11%; Blood pressure < 160 (systolic) and 100 (diastolic) mm Hg
Triglyceride levels < 500 mg/dl.

Exclusion criteria

Pregnancy or breast-feeding
Previous use of insulin or oral antidiabetic drugs
Investigational drug within the previous 3 months
Use of agents affecting glycemic control (systemic steroids and weight loss drugs)
Patients with history of alcohol or illicit drug abuse
Patients with liver enzymes higher than three times the upper limit of normal
Serum creatinine > 1.4 mg/dl.