Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00219440
Status:
COMPLETED
Last Update Posted:
2016-01-25
First Post:
2005-09-14
Brief Title:
A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
Sponsor:
Pennington Biomedical Research Center
Organization:
Pennington Biomedical Research Center
Study Overview
Official Title:
A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAKE II
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None