- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01542775
Effects of Exercise on sRAGE Levels and Cardiometabolic Risk Factors
March 1, 2012 updated by: K. M. Choi, Korea University
The purpose of this study is to examine the effects of exercise on diverse cardiometabolic risk factors and indicators of atherosclerosis in patients with type 2 diabetes mellitus (T2DM).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 139-711
- Eulji University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- type 2 diabetes
- stable body weight
- sedentary lifestyle
Exclusion Criteria:
- smoked cigarettes
- cardiovascular disease
- chronic kidney
- chronic liver disease
- pregnant or breastfeeding
- any other major illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Exercise
|
12 weeks Aerobic exercise
|
|
Placebo Comparator: Control
|
maintaining usual activities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
change from baseline in soluble receptor for advanced glycation endproducts (sRAGE) after 12 weeks of aerobic exercise
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anthropometric parameters
Time Frame: 12 weeks
|
body weight, waist circumference, body fat percentage, visceral fat area
|
12 weeks
|
|
biochemical parameters
Time Frame: 12 weeks
|
HbA1c, apolipoprotein B, free fatty acid
|
12 weeks
|
|
energy expenditure
Time Frame: 12 weeks
|
activity energy expenditure, total energy expenditure
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
February 20, 2012
First Submitted That Met QC Criteria
March 1, 2012
First Posted (Estimate)
March 2, 2012
Study Record Updates
Last Update Posted (Estimate)
March 2, 2012
Last Update Submitted That Met QC Criteria
March 1, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- Exer(sRAGE)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.