Diabetes Mellitus
Conditions
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
Interventions
OTHERActos plus standard diet
Actos plus standard diet
OTHERActos plus structured diet
Actos plus structured diet
OTHERMetformin plus standard diet
Metformin plus standard diet
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Men and women age 35 to 75 who have type 2 diabetes mellitus
Exclusion criteria
* Individuals with co-existing other diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glucose | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in lipids | 4 months |
| blood pressure | 4 months |
Countries
United States
Outcome results
None listed