We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737347
First Posted: August 19, 2008
Last Update Posted: August 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda
Information provided by:
Northwestern University
August 15, 2008
August 19, 2008
August 19, 2008
September 2003
March 2007   (Final data collection date for primary outcome measure)
change in body weight [ Time Frame: 24 weeks ]
Same as current
No Changes Posted
change in body composition [ Time Frame: 24 weeks ]
Same as current
Not Provided
Not Provided
 
Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone
Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone
The purpose of the study is to investigate the effectiveness of three lifestyle treatment programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain and to measure the composition of the change in body weight.
The three lifestyle interventions were usual care (1 visit), standard care (4 total visits) and intensive care (10 total visits)
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Type 2 Diabetes
  • Obesity
Behavioral: Lifestyle modification
lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling
Other Name: lifestyle behavioral counseling
  • No Intervention: 1
    usual care. Subjects had one 90 minute visit with registered dietitian
  • Active Comparator: 2.
    Standard care. Subjects had 4 sessions with registered dietitian
    Intervention: Behavioral: Lifestyle modification
  • Active Comparator: 3
    Intensive care. subjects had 10 visits with registered dietitian
    Intervention: Behavioral: Lifestyle modification
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
April 2008
March 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 2 diabetes with BMI 27 or greater, glycated hemoglobin 7% or greater

Exclusion Criteria:

  • insulin treated
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00737347
0309-015
No
Not Provided
Not Provided
Robert F. Kushner, MD, Northwestern University
Northwestern University
Takeda
Principal Investigator: Robert F Kushner, MD Northwestern University
Northwestern University
August 2008

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