Lifestyle Modification for Obesity-Related Type 2 Diabetes

A Randomized, Controlled Trial of a Low-Carbohydrate, Ketogenic Diet Versus a Low-Glycemic Index Diet for Obesity-Related Type 2 Diabetes

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00415688

Enrollment

Registered

2006-12-25

Start date

2004-07-31

Completion date

2006-01-31

Last updated

2006-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight, Type 2 Diabetes Mellitus

Keywords

lifestyle modification, weight loss, hyperglycemia, hypoglycemic agents

Brief summary

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.

Interventions

BEHAVIORALLow carbohydrate, ketogenic diet

BEHAVIORALLow glycemic index, reduced calorie diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Hemoglobin A1c	—

Secondary

Measure	Time frame
Body weight	—
Serum lipoproteins	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026