A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 35 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | February 2003 |
| End Date: | December 2006 |
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.
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
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
Inclusion Criteria:
- Men and women age 35 to 75 who have type 2 diabetes mellitus
Exclusion Criteria:
- Individuals with co-existing other diseases
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