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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
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, exercise, diet, insulin resistance

Eligibility Criteria

20 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

First Posted
April 21, 2008
Last Updated
April 22, 2008
Sponsor
Queen's University
Collaborators
Canadian Institutes of Health Research (CIHR)
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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

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Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss

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