Status:
COMPLETED
Dietary Control of Type 2 Diabetes: Low-Carbohydrate Mediterranean Diet Versus Low-Fat Diet
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-75 years
Phase:
NA
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 obesit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00725257
Start Date
June 1 2004
End Date
December 1 2007
Last Update
July 30 2008
Active Locations (1)
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1
Department of Geriatrics and Metabolic Diseases
Naples, Italy, 80138