NCT00219440

A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Actos plus standard diet	Actos plus standard diet
OTHER	Actos plus structured diet	Actos plus structured diet
OTHER	Metformin plus standard diet	Metformin plus standard diet

Timeline

• Start date: 2003-02-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2005-09-22
• Last updated: 2016-01-25

Locations

1 site across 1 country: United States