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

July 28, 2008
July 28, 2008
June 2004
September 2007   (final data collection date for primary outcome measure)
Hemoglobin A1c [ Time Frame: Every sixth month ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Time to introduction of an oral hypoglycemic agent [ Time Frame: Every year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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%.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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%.
  • 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%.
  • Active Comparator: 1
    Low-carbohydrate, energy-restricted, Mediterranean-type diet
    Intervention: Other: Mediterranean diet
  • Active Comparator: 2
    Low-fat diet
    Intervention: Other: Low-fat diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
215
December 2007
September 2007   (final data collection date for primary outcome measure)

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.
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00725257
DGMM/4/2004
No
Department of Geriatrics and Metabolic Diseases
Second University of Naples
Not Provided
Principal Investigator: Dario Giugliano, MD,PhD Department of Geriatrics and Metabolic Diseases
Second University of Naples
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP