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

This study has been completed.
Information provided by (Responsible Party):
George A. Bray, Pennington Biomedical Research Center Identifier:
First received: September 14, 2005
Last updated: January 22, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Diabetes Mellitus
Other: Actos plus standard diet
Other: Actos plus structured diet
Other: Metformin plus standard diet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS

Resource links provided by NLM:

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • glucose [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Change in lipids [ Time Frame: 4 months ]
  • blood pressure [ Time Frame: 4 months ]

Estimated Enrollment: 60
Study Start Date: February 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00219440

United States, Louisiana
Pennington Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Principal Investigator: George A Bray, MD Pennington Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: George A. Bray, Professor, Adjunct, Pennington Biomedical Research Center Identifier: NCT00219440     History of Changes
Other Study ID Numbers: PBRC 24005
Study First Received: September 14, 2005
Last Updated: January 22, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Weight Gain
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 28, 2017