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

Phase 4

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: Actos plus structured diet; Other: Actos plus standard diet; Other: Metformin plus standard diet

• Registration Number: NCT00219440
• Lead Sponsor: Pennington Biomedical Research Center

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

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• Individuals with co-existing other diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Actos plus structured diet	Actos plus structured diet
A	Actos plus standard diet	ACTOS plus standard diet
C	Metformin plus standard diet	Metformin plus standard diet

Primary Outcome Measures

Name	Time	Method
glucose	4 months

Secondary Outcome Measures

Name	Time	Method
Change in lipids	4 months
blood pressure	4 months

Trial Locations

Locations (1)

Pennington Center; 🇺🇸 Baton Rouge, Louisiana, United States