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Effects of Exercise on sRAGE Levels and Cardiometabolic Risk Factors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542775
First Posted: March 2, 2012
Last Update Posted: March 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
K. M. Choi, Korea University
  Purpose
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).

Condition Intervention
Type 2 Diabetes Behavioral: Aerobic Exercise Group Behavioral: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by K. M. Choi, Korea University:

Primary Outcome Measures:
  • change from baseline in soluble receptor for advanced glycation endproducts (sRAGE) after 12 weeks of aerobic exercise [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • anthropometric parameters [ Time Frame: 12 weeks ]
    body weight, waist circumference, body fat percentage, visceral fat area

  • biochemical parameters [ Time Frame: 12 weeks ]
    HbA1c, apolipoprotein B, free fatty acid

  • energy expenditure [ Time Frame: 12 weeks ]
    activity energy expenditure, total energy expenditure


Enrollment: 80
Study Start Date: January 2010
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Behavioral: Control Group
maintaining usual activities
Active Comparator: Exercise Behavioral: Aerobic Exercise Group
12 weeks Aerobic exercise

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542775


Locations
Korea, Republic of
Eulji University School of Medicine
Seoul, Korea, Republic of, 139-711
Sponsors and Collaborators
Korea University
  More Information

Responsible Party: K. M. Choi, Clinical Professor, Korea University
ClinicalTrials.gov Identifier: NCT01542775     History of Changes
Other Study ID Numbers: Exer(sRAGE)
First Submitted: February 20, 2012
First Posted: March 2, 2012
Last Update Posted: March 2, 2012
Last Verified: February 2012