NCT00415688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed
Last Updated

December 25, 2006

Status Verified

December 1, 2006

First QC Date

December 21, 2006

Last Update Submit

December 21, 2006

Conditions

Type 2 Diabetes MellitusOverweightObesity

Keywords

lifestyle modificationweight losshyperglycemiahypoglycemic agents

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

Secondary Outcomes (2)

  • Body weight

  • Serum lipoproteins

Interventions

Low carbohydrate, ketogenic dietBEHAVIORAL
Low glycemic index, reduced calorie dietBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightObesityWeight LossHyperglycemia

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Eric C Westman, MD MHS

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 25, 2006

Study Start

July 1, 2004

Study Completion

January 1, 2006

Last Updated

December 25, 2006

Record last verified: 2006-12

Locations

US(1)