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

This study has been completed.
Sponsor:
Information provided by:
Second University of Naples
ClinicalTrials.gov Identifier:
NCT00725257
First received: July 28, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Other: Mediterranean diet
Other: Low-fat diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Second University of Naples:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: Every sixth month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to introduction of an oral hypoglycemic agent [ Time Frame: Every year ] [ Designated as safety issue: Yes ]

Enrollment: 215
Study Start Date: June 2004
Study Completion Date: December 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00725257

Locations
Italy
Department of Geriatrics and Metabolic Diseases
Naples, Italy, 80138
Sponsors and Collaborators
Second University of Naples
Investigators
Principal Investigator: Dario Giugliano, MD,PhD Department of Geriatrics and Metabolic Diseases
  More Information

Publications:
Responsible Party: Department of Geriatrics and Metabolic Diseases
ClinicalTrials.gov Identifier: NCT00725257     History of Changes
Other Study ID Numbers: DGMM/4/2004
Study First Received: July 28, 2008
Last Updated: July 28, 2008
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 26, 2014