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

Effect of a Low-Carbohydrate Mediterranean Diet or Low-Fat Diet in Newly-Diagnosed Type 2 Diabetic Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00725257

Enrollment

215

Registered

2008-07-30

Start date

2004-06-30

Completion date

2007-12-31

Last updated

2008-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

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%.

Interventions

OTHERMediterranean diet

The recommended composition of the dietary regimen was as follows: Carbohydrate 40 to 50%, protein 15 to 20%; fat 30 to 40%; saturated fat less than 10%.

OTHERLow-fat diet

The recommended composition of the dietary regimen was as follows: Fat less than 30%; carbohydrate 50 to 60%, protein 15 to 20%; saturated fat less than 10%.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Hemoglobin A1c	Every sixth month

Secondary

Measure	Time frame
Time to introduction of an oral hypoglycemic agent	Every year

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026