Back to resultsPrevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone
Primary Purpose
Type 2 Diabetes, Obesity
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lifestyle modification
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes focused on measuring type 2 diabetes, obesity, weight gain, thiazolidinediones
Eligibility Criteria
Inclusion Criteria:
- type 2 diabetes with BMI 27 or greater, glycated hemoglobin 7% or greater
Exclusion Criteria:
- insulin treated
Sites / Locations
- Northwestern Memorial Hospital Wellness Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
1
2.
3
Arm Description
usual care. Subjects had one 90 minute visit with registered dietitian
Standard care. Subjects had 4 sessions with registered dietitian
Intensive care. subjects had 10 visits with registered dietitian
Outcomes
Primary Outcome Measures
change in body weight
Secondary Outcome Measures
change in body composition
Full Information
NCT ID
NCT00737347
First Posted
August 15, 2008
Last Updated
August 18, 2008
Sponsor
Northwestern University
Collaborators
Takeda
1. Study Identification
Unique Protocol Identification Number
NCT00737347
Brief Title
Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone
Official Title
Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Northwestern University
Collaborators
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
The three lifestyle interventions were usual care (1 visit), standard care (4 total visits) and intensive care (10 total visits)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Obesity
Keywords
type 2 diabetes, obesity, weight gain, thiazolidinediones
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
usual care. Subjects had one 90 minute visit with registered dietitian
Arm Title
2.
Arm Type
Active Comparator
Arm Description
Standard care. Subjects had 4 sessions with registered dietitian
Arm Title
3
Arm Type
Active Comparator
Arm Description
Intensive care. subjects had 10 visits with registered dietitian
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification
Other Intervention Name(s)
lifestyle behavioral counseling
Intervention Description
lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling
Primary Outcome Measure Information:
Title
change in body weight
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
change in body composition
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
type 2 diabetes with BMI 27 or greater, glycated hemoglobin 7% or greater
Exclusion Criteria:
insulin treated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert F Kushner, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital Wellness Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone
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