Safety and Efficacy of Low Carbohydrate Diet in Obesity and Type 2 DM: RCT

Objectives:

This study is designed to address the hypothesis that in obese patients with type 2 DM, a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over a 24 months period will:

• Primary:

1. Cause 5% greater reduction in body weight in patients with obesity and type 2 DM;
2. Be safe and will not have any detrimental effects on serum lipid concentrations

• Secondary:

1. Lead to a greater reduction in HbA1c and fasting serum glucose and insulin concentration;
2. Lead to reduction in body fat content;
3. Cause greater reduction in serum triglyceride concentration;
4. Cause no significant changes in proteinuria, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), creatinine and uric acid concentrations

• Exploratory: