Lifestyle Modification for Obesity-Related Type 2 Diabetes

Robert C. Atkins Foundation90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus Overweight Obesity

Interventions

Low carbohydrate, ketogenic dietBEHAVIORAL

Low glycemic index, reduced calorie dietBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Health System

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Hemoglobin A1c

Secondary Outcomes

Body weight

Serum lipoproteins

Data from ClinicalTrials.gov

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