Low Carbohydrate Diet Compared to Calorie and Fat Restricted Diet in Patients With Obesity and Type II Diabetes

Completed · Phase 3

Conditions studied: Obesity, Type 2 Diabetes, Hyperlipidemia

In brief

This study is designed to address the hypothesis that in obese patients with type 2 diabetes mellitus (DM), a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over 24 months will cause 5% greater reduction in body weight in patients with obesity and type 2 DM, be safe, and will not have any detrimental effects on serum lipid concentrations.

Key facts

Study ID

NCT00108459

Run by

US Department of Veterans Affairs

People needed

156

Starts

2004-09-01

Expected to finish

2007-12-01

Last updated by the study team

2009-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects > 18 years of age
• Clinical diagnosis of type 2 diabetes mellitus or on insulin or oral hypoglycemic agents
• Body mass index of > 30 kg/m2
• The subject must we willing and able to monitor their blood glucose with a glucometer at least 2 times per week.

Where it is running

• VA Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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