Reduction of Abdominal Obesity and Insulin Resistance in Women
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Diet Weight Loss
Exercise Weight Loss
Exercise Without Weight Loss
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, exercise, diet, insulin resistance
Eligibility Criteria
Inclusion Criteria:
- Premenopausal women
Exclusion Criteria:
- Smokers and diabetics
Sites / Locations
- Queen's University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Active Comparator
Arm Label
C
DWL
EWL
EWS
Arm Description
Control
Diet Weight Loss
Exercise Weight Loss
Exercise Without Weight Loss
Outcomes
Primary Outcome Measures
Abdominal Obesity
Insulin Resistance
Secondary Outcome Measures
Full Information
NCT ID
NCT00664495
First Posted
April 21, 2008
Last Updated
April 22, 2008
Sponsor
Queen's University
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT00664495
Brief Title
Reduction of Abdominal Obesity and Insulin Resistance in Women
Official Title
Reduction of Abdominal Obesity and Insulin Resistance in Women
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Queen's University
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study was to assess the effects of equivalent diet- or exercise-induced weight loss and related insulin resistance in abdominally obese women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, exercise, diet, insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
C
Arm Type
No Intervention
Arm Description
Control
Arm Title
DWL
Arm Type
Active Comparator
Arm Description
Diet Weight Loss
Arm Title
EWL
Arm Type
Active Comparator
Arm Description
Exercise Weight Loss
Arm Title
EWS
Arm Type
Active Comparator
Arm Description
Exercise Without Weight Loss
Intervention Type
Behavioral
Intervention Name(s)
Diet Weight Loss
Intervention Type
Behavioral
Intervention Name(s)
Exercise Weight Loss
Intervention Type
Behavioral
Intervention Name(s)
Exercise Without Weight Loss
Primary Outcome Measure Information:
Title
Abdominal Obesity
Time Frame
4 months
Title
Insulin Resistance
Time Frame
4 Months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Premenopausal women
Exclusion Criteria:
Smokers and diabetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Ross, PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
15166299
Citation
Ross R, Janssen I, Dawson J, Kungl AM, Kuk JL, Wong SL, Nguyen-Duy TB, Lee S, Kilpatrick K, Hudson R. Exercise-induced reduction in obesity and insulin resistance in women: a randomized controlled trial. Obes Res. 2004 May;12(5):789-98. doi: 10.1038/oby.2004.95.
Results Reference
result
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Reduction of Abdominal Obesity and Insulin Resistance in Women
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