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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00725257
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : July 30, 2008
Information provided by:
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%.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Mediterranean diet Other: Low-fat diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of a Low-Carbohydrate Mediterranean Diet or Low-Fat Diet in Newly-Diagnosed Type 2 Diabetic Patients
Study Start Date : June 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

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%.

Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: Every sixth month ]

Secondary Outcome Measures :
  1. Time to introduction of an oral hypoglycemic agent [ Time Frame: Every year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00725257

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Department of Geriatrics and Metabolic Diseases
Naples, Italy, 80138
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
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Principal Investigator: Dario Giugliano, MD,PhD Department of Geriatrics and Metabolic Diseases
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Department of Geriatrics and Metabolic Diseases Identifier: NCT00725257    
Other Study ID Numbers: DGMM/4/2004
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: July 30, 2008
Last Verified: July 2008
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases