Lifestyle Modification for Obesity-Related Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Overweight Obesity

Keywords

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lifestyle modification weight loss hyperglycemia hypoglycemic agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Low carbohydrate, ketogenic diet

Intervention Type BEHAVIORAL

Low glycemic index, reduced calorie diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Eric C Westman, MD MHS

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

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Duke University Health System

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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AF001

Identifier Type: -

Identifier Source: org_study_id