NCT00219440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_4 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

3.8 years

First QC Date

September 14, 2005

Last Update Submit

January 22, 2016

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • glucose

    4 months

Secondary Outcomes (2)

  • Change in lipids

    4 months

  • blood pressure

    4 months

Study Arms (3)

A

EXPERIMENTAL

ACTOS plus standard diet

Other: Actos plus standard diet

B

EXPERIMENTAL

Actos plus structured diet

Other: Actos plus structured diet

C

EXPERIMENTAL

Metformin plus standard diet

Other: Metformin plus standard diet

Interventions

Actos plus standard dietOTHER

Actos plus standard diet

A
Actos plus structured dietOTHER

Actos plus structured diet

B
Metformin plus standard dietOTHER

Metformin plus standard diet

C

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Individuals with co-existing other diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

  • Martin CK, Gupta AK, Smith SR, Greenway FL, Han H, Bray GA. Effect of pioglitazone on energy intake and ghrelin in diabetic patients. Diabetes Care. 2010 Apr;33(4):742-4. doi: 10.2337/dc09-1600. Epub 2010 Jan 12.

    PMID: 20067964DERIVED

  • 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. doi: 10.1111/j.1463-1326.2008.00965.x.

    PMID: 19267711DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

PioglitazoneMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • George A Bray, MD

    Pennington Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Adjunct

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

February 1, 2003

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

January 25, 2016

Record last verified: 2016-01

Locations

US(1)