Effect of a Low-Carbohydrate Mediterranean Diet or Low-Fat Diet in Newly-Diagnosed Type 2 Diabetic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 215
- Locations
- 1
- Primary Endpoint
- Hemoglobin A1c
Study Overview
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%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
1
Low-carbohydrate, energy-restricted, Mediterranean-type diet
Intervention: Mediterranean diet (Other)
2
Low-fat diet
Intervention: Low-fat diet (Other)
Outcomes
Primary Outcomes
Hemoglobin A1c
Time Frame: Every sixth month
Secondary Outcomes
- Time to introduction of an oral hypoglycemic agent(Every year)