A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS (TAKE II)

Pennington Biomedical Research Center

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Other: Metformin plus standard diet; Other: Actos plus structured diet; Other: Actos plus standard diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00219440

PBRC 24005

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women age 35 to 75 who have type 2 diabetes mellitus

Exclusion criteria

• Individuals with co-existing other diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

A

Experimental group

Description:

ACTOS plus standard diet

Treatment:

Other: Actos plus standard diet

B

Experimental group

Description:

Actos plus structured diet

Treatment:

Other: Actos plus structured diet

C

Experimental group

Description:

Metformin plus standard diet

Treatment:

Other: Metformin plus standard diet