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A Portion-Controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
This study is ongoing, but not recruiting participants.
Study NCT00219440   Information provided by Pennington Biomedical Research Center
First Received: September 14, 2005   Last Updated: March 3, 2008   History of Changes

September 14, 2005
March 3, 2008
February 2003
December 2006   (final data collection date for primary outcome measure)
glucose [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Change in body fat
Complete list of historical versions of study NCT00219440 on ClinicalTrials.gov Archive Site
  • Change in lipids [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Change in lipids, glucose, blood pressure
 
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
Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Diabetes Mellitus
  • Other: Actos plus standard diet
  • Other: Actos plus structured diet
  • Other: Metformin plus standard diet
  • Experimental: ACTOS plus standard diet
  • Experimental: Actos plus structured diet
  • Experimental: Metformin plus standard diet
Gupta AK, Smith SR, Greenway FL, Bray GA. Pioglitazone treatment in type 2 diabetes mellitus when combined with portion control diet modifies the metabolic syndrome. Diabetes Obes Metab. 2009 Apr;11(4):330-7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
60
December 2008
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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00219440
George Bray, MD, Pennington Biomedical Research Center
TAKE II
Pennington Biomedical Research Center
 
Principal Investigator: George A Bray, MD Pennington Center
Pennington Biomedical Research Center
March 2008

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