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

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00737347
First received: August 15, 2008
Last updated: August 18, 2008
Last verified: August 2008

August 15, 2008
August 18, 2008
September 2003
March 2007   (final data collection date for primary outcome measure)
change in body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00737347 on ClinicalTrials.gov Archive Site
change in body composition [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00737347
0309-015
No
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