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NCT00198926 Clinical Trial

Type 2 Diabetes Controlled Eating Experiment

Type 2 Diabetes Mellitus Clinical Trial

Official title:
Use of Modified Foods in the Dietary Treatment of Type II Diabetes Mellitus: Short Term Feeding Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00198926
Other study ID # ADA2000-02
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated September 13, 2005
Start date May 2000
Est. completion date August 2001

Study information
Verified date September 2001
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 2001
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

Intervention

Behavioral:
• covert v overt nutrition labeling

• varying meal nutrition manipulation

Locations
Country Name City State
United States Johns Hopkins University Baltimore Maryland

Sponsors (2)
Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary glucose control
Primary caloric compensation
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