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

This study has been completed.
Sponsor:
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00219440
First received: September 14, 2005
Last updated: February 2, 2010
Last verified: February 2010
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • glucose [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in lipids [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Individuals with co-existing other diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219440

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

No publications provided by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: George Bray, MD, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00219440     History of Changes
Other Study ID Numbers: TAKE II
Study First Received: September 14, 2005
Last Updated: February 2, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Weight Gain
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
 Signs and Symptoms
Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013