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
  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:


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 April 17, 2014