Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss
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:
- Men between 20 and 60 yrs
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
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
NCT00664547
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
NCT00664547
Brief Title
Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss
Official Title
Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
December 1999 (Actual)
Study Completion Date
December 1999 (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 trial was to examine the independent effects of equivalent diet- or exercise-induced weight loss on obesity and related cardiovascular health risk factors. We hypothesized that exercise would result in greater reductions in obesity and health risk factors that equivalent diet (caloric restriction).
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
8. Arms, Groups, and Interventions
Arm Title
C
Arm Type
No Intervention
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
3 months
Title
Insulin Resistance
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men between 20 and 60 yrs
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
10896648
Citation
Ross R, Dagnone D, Jones PJ, Smith H, Paddags A, Hudson R, Janssen I. Reduction in obesity and related comorbid conditions after diet-induced weight loss or exercise-induced weight loss in men. A randomized, controlled trial. Ann Intern Med. 2000 Jul 18;133(2):92-103. doi: 10.7326/0003-4819-133-2-200007180-00008.
Results Reference
result
Learn more about this trial
Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss
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