Back to resultsA Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS (TAKE II)
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Actos plus standard diet
Actos plus structured diet
Metformin plus standard diet
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: Men and women age 35 to 75 who have type 2 diabetes mellitus Exclusion Criteria: Individuals with co-existing other diseases
Sites / Locations
- Pennington Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A
B
C
Arm Description
ACTOS plus standard diet
Actos plus structured diet
Metformin plus standard diet
Outcomes
Primary Outcome Measures
glucose
Secondary Outcome Measures
Change in lipids
blood pressure
Full Information
NCT ID
NCT00219440
First Posted
September 14, 2005
Last Updated
January 22, 2016
Sponsor
Pennington Biomedical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00219440
Brief Title
A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
Acronym
TAKE II
Official Title
A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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
ACTOS plus a standard diet
ACTOS plus a portion-controlled diet
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
ACTOS plus standard diet
Arm Title
B
Arm Type
Experimental
Arm Description
Actos plus structured diet
Arm Title
C
Arm Type
Experimental
Arm Description
Metformin plus standard diet
Intervention Type
Other
Intervention Name(s)
Actos plus standard diet
Intervention Description
Actos plus standard diet
Intervention Type
Other
Intervention Name(s)
Actos plus structured diet
Intervention Description
Actos plus structured diet
Intervention Type
Other
Intervention Name(s)
Metformin plus standard diet
Intervention Description
Metformin plus standard diet
Primary Outcome Measure Information:
Title
glucose
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change in lipids
Time Frame
4 months
Title
blood pressure
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women age 35 to 75 who have type 2 diabetes mellitus
Exclusion Criteria:
Individuals with co-existing other diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George A Bray, MD
Organizational Affiliation
Pennington Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20067964
Citation
Martin CK, Gupta AK, Smith SR, Greenway FL, Han H, Bray GA. Effect of pioglitazone on energy intake and ghrelin in diabetic patients. Diabetes Care. 2010 Apr;33(4):742-4. doi: 10.2337/dc09-1600. Epub 2010 Jan 12.
Results Reference
derived
PubMed Identifier
19267711
Citation
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. doi: 10.1111/j.1463-1326.2008.00965.x.
Results Reference
derived
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A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
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