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Effects of Exercise on sRAGE Levels and Cardiometabolic Risk Factors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
K. M. Choi, Korea University
ClinicalTrials.gov Identifier:
NCT01542775
First received: February 20, 2012
Last updated: March 1, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anthropometric parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    body weight, waist circumference, body fat percentage, visceral fat area

  • biochemical parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    HbA1c, apolipoprotein B, free fatty acid

  • energy expenditure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542775

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

No publications provided

Responsible Party: K. M. Choi, Clinical Professor, Korea University
ClinicalTrials.gov Identifier: NCT01542775     History of Changes
Other Study ID Numbers: Exer(sRAGE)
Study First Received: February 20, 2012
Last Updated: March 1, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013