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

July 28, 2008 updated by: University of Campania "Luigi Vanvitelli"

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

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%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80138
        • Department of Geriatrics and Metabolic Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Low-carbohydrate, energy-restricted, Mediterranean-type diet
Other: Mediterranean 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%.
Active Comparator: 2
Low-fat diet
Other: Low-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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1c
Time Frame: Every sixth month
Every sixth month

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to introduction of an oral hypoglycemic agent
Time Frame: Every year
Every year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Investigators

  • Principal Investigator: Dario Giugliano, MD,PhD, Department of Geriatrics and Metabolic Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 30, 2008

Study Record Updates

Last Update Posted (Estimate)

July 30, 2008

Last Update Submitted That Met QC Criteria

July 28, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGMM/4/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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