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

January 22, 2016 updated by: George A. Bray, Pennington Biomedical Research Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Individuals with co-existing other diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
ACTOS plus standard diet
Other: Actos plus standard diet
Actos plus standard diet
Experimental: B
Actos plus structured diet
Other: Actos plus structured diet
Actos plus structured diet
Experimental: C
Metformin plus standard diet
Other: Metformin plus standard diet
Metformin plus standard diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glucose
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: 4 months
4 months
Change in lipids
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Investigators

  • Principal Investigator: George A Bray, MD, Pennington Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 25, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 24005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Actos plus standard diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe