Diabetes Mellitus Clinical Trial
Official title:
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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