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NCT00219440 Clinical Trial

A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS

Diabetes Mellitus Clinical Trial

— TAKE II  

Official title:
A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00219440
Other study ID # PBRC 24005
Secondary ID
Status Completed
Phase Phase 4
First received September 14, 2005
Last updated January 22, 2016
Start date February 2003
Est. completion date December 2006

Study information
Verified date January 2016
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

We hypothesized that a portion controlled diet would prevent the weight gain associated with the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a standard diet, pioglitazone and a portion-controlled diet and metformin with a standard diet.

Description:

A total of 60 male and female type 2 diabetic subjects will be recruited and randomized into 1 of 3 treatment groups for the 4 months long trial

1. ACTOS plus a standard diet

2. ACTOS plus a portion-controlled diet

3. Metformin plus a standard diet. The end-point of the trial is the change in body fat content from baseline to the end of the trial

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 75 Years
Eligibility Inclusion Criteria:

- Men and women age 35 to 75 who have type 2 diabetes mellitus

Exclusion Criteria:

- Individuals with co-existing other diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Actos plus standard diet
Actos plus standard diet
• Actos plus structured diet
Actos plus structured diet
• Metformin plus standard diet
Metformin plus standard diet

Locations
Country Name City State
United States Pennington Center Baton Rouge Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary glucose 4 months No
Secondary Change in lipids 4 months No
Secondary blood pressure 4 months No
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