A Portion-Controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS - Full Text View

Sponsor:	Pennington Biomedical Research Center
Information provided by:	Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:	NCT00219440

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Portion-Controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diets

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Metformin Metformin hydrochloride

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
Estimated Study Completion Date:	December 2008
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental ACTOS plus standard diet	Other: Actos plus standard diet Actos plus standard diet
B: Experimental Actos plus structured diet	Other: Actos plus structured diet Actos plus structured diet
C: Experimental 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

ACTOS plus a standard diet
ACTOS plus a portion-controlled diet
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 National Clinical Trials Identifier (NCT ID):

Gupta AK, Smith SR, Greenway FL, Bray GA. Pioglitazone treatment in type 2 diabetes mellitus when combined with portion control diet modifies the metabolic syndrome. Diabetes Obes Metab. 2009 Apr;11(4):330-7.

Responsible Party:	Pennington Biomedical Research Center ( George Bray, MD )
Study ID Numbers:	TAKE II
Study First Received:	September 14, 2005
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00219440 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Metabolic Diseases
Pioglitazone
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Weight Gain

Pharmacologic Actions
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Body Weight Changes
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009