NCT00198926

Brief Summary

A short-term feeding study in type 2 diabetics manipulating the fat and caloric values of meals to assess both compensation and glucose control, both covertly and overtly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started May 2000

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

September 1, 2001

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • glucose control

  • caloric compensation

Interventions

covert v overt nutrition labelingBEHAVIORAL
varying meal nutrition manipulationBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • type 2 diabetic, age 18+, informed consent, able to eat 3 meals/day 1 day/week at clinic

You may not qualify if:

  • non-diabetic, type 1 diabetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lawrence J Cheskin, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
ECT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

May 1, 2000

Study Completion

August 1, 2001

Last Updated

September 20, 2005

Record last verified: 2001-09

Locations

US(1)