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A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS (TAKE II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219440
First Posted: September 22, 2005
Last Update Posted: January 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
George A. Bray, Pennington Biomedical Research Center
September 14, 2005
September 22, 2005
January 25, 2016
February 2003
December 2006   (Final data collection date for primary outcome measure)
glucose [ Time Frame: 4 months ]
Change in body fat
Complete list of historical versions of study NCT00219440 on ClinicalTrials.gov Archive Site
  • Change in lipids [ Time Frame: 4 months ]
  • blood pressure [ Time Frame: 4 months ]
Change in lipids, glucose, blood pressure
Not Provided
Not Provided
 
A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
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.

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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus
  • Other: Actos plus standard diet
    Actos plus standard diet
  • Other: Actos plus structured diet
    Actos plus structured diet
  • Other: Metformin plus standard diet
    Metformin plus standard diet
  • Experimental: A
    ACTOS plus standard diet
    Intervention: Other: Actos plus standard diet
  • Experimental: B
    Actos plus structured diet
    Intervention: Other: Actos plus structured diet
  • Experimental: C
    Metformin plus standard diet
    Intervention: Other: Metformin plus standard diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2006
December 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Individuals with co-existing other diseases
Sexes Eligible for Study: All
35 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00219440
PBRC 24005
Yes
Not Provided
Not Provided
George A. Bray, Pennington Biomedical Research Center
Pennington Biomedical Research Center
Not Provided
Principal Investigator: George A Bray, MD Pennington Center
Pennington Biomedical Research Center
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP