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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Mediterranean diet; Other: Low-fat diet

• Registration Number: NCT00725257
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2007-09
• Study Completion: 2007-12
• Status Verified: 2008-07
• Study First Submitted: 2008-07-28
• Study First Submitted QC: 2008-07-28
• Last Update Submitted: 2008-07-28
• Study First Posted: 2008-07-30
• Last Update Posted: 2008-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Mediterranean diet	Low-carbohydrate, energy-restricted, Mediterranean-type diet
2	Low-fat diet	Low-fat diet

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	Every sixth month

Secondary Outcome Measures

Name	Time	Method
Time to introduction of an oral hypoglycemic agent	Every year

Trial Locations

Locations (1)

Department of Geriatrics and Metabolic Diseases; 🇮🇹 Naples, Italy