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

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

March 3, 2008

Start Date ^ICMJE

February 2003

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

glucose [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in body fat

Change History

Complete list of historical versions of study NCT00219440 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Change in lipids, glucose, blood pressure

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Other: Actos plus standard diet
Other: Actos plus structured diet
Other: Metformin plus standard diet

Study Arms / Comparison Groups

Experimental: ACTOS plus standard diet
Experimental: Actos plus structured diet
Experimental: Metformin plus standard diet

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2008

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Individuals with co-existing other diseases

Gender

Both

Ages

35 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00219440

Responsible Party

George Bray, MD, Pennington Biomedical Research Center

Study ID Numbers ^ICMJE

TAKE II

Study Sponsor ^ICMJE

Pennington Biomedical Research Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

George A Bray, MD

Pennington Center

Information Provided By

Pennington Biomedical Research Center

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP