Lifestyle Modification for Obesity-Related Type 2 Diabetes

Robert C. Atkins Foundation

Status and phase: Completed; Phase 4

Conditions: Overweight; Type 2 Diabetes Mellitus; Obesity

Treatments: Behavioral: Low glycemic index, reduced calorie diet; Behavioral: Low carbohydrate, ketogenic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00415688

AF001

Details and patient eligibility

About

Dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary evidence suggests that low carbohydrate diets improve glycemic control when accompanied by weight loss. To determine if glycemic control can be improved by varying dietary carbohydrate during weight loss, we compared two weight loss diets with different carbohydrate levels for the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetes mellitus for at least one year
• hgba1c > 6.0
• BMI from 27-50 kg/m2

Exclusion criteria

• Unstable medical condition
• Serious medical condition
• AST or ALT > 100
• Serum creatinine > 1.5

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)