Type 2 Diabetes Controlled Eating Experiment
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
covert v overt nutrition labeling
varying meal nutrition manipulation
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: type 2 diabetic, age 18+, informed consent, able to eat 3 meals/day 1 day/week at clinic Exclusion Criteria: non-diabetic, type 1 diabetic
Sites / Locations
- Johns Hopkins University
Outcomes
Primary Outcome Measures
glucose control
caloric compensation
Secondary Outcome Measures
Full Information
NCT ID
NCT00198926
First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
American Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT00198926
Brief Title
Type 2 Diabetes Controlled Eating Experiment
Official Title
Use of Modified Foods in the Dietary Treatment of Type II Diabetes Mellitus: Short Term Feeding Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2001
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
American Diabetes Association
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
covert v overt nutrition labeling
Intervention Type
Behavioral
Intervention Name(s)
varying meal nutrition manipulation
Primary Outcome Measure Information:
Title
glucose control
Title
caloric compensation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
type 2 diabetic, age 18+, informed consent, able to eat 3 meals/day 1 day/week at clinic
Exclusion Criteria:
non-diabetic, type 1 diabetic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence J Cheskin, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Type 2 Diabetes Controlled Eating Experiment
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