Effects of Lifestyle Modification on Metabolic Parameters in Type 2 Diabetic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Inha University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Inha University Hospital
ClinicalTrials.gov Identifier:
NCT01051089
First received: January 15, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 15, 2010
January 15, 2010
June 2009
December 2010   (final data collection date for primary outcome measure)
HbA1c, serum adipokine levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Body composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Pulse wave velocity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Insulin secretion and sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • VO2max [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Lifestyle Modification on Metabolic Parameters in Type 2 Diabetic Patients
Effects of Lifestyle Modification Focusing on Exercise Intervention on Risk of Atherosclerosis and Metabolic Parameters in Type 2 Diabetic Patients

The study is a randomized controlled study comparing the metabolic effect of a 3 month intensive lifestyle modification intervention in Korean type 2 diabetic patients.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Behavioral: Lifestyle modification
Exercise and diet education
  • Experimental: Lifestyle modification
    supervised exercise with diet education
    Intervention: Behavioral: Lifestyle modification
  • No Intervention: Control
    Control (ordinary care with usual education)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 25 or older,
  • type 2 diabetes mellitus,
  • HbA1c 6.5-10% BMI 23 or higher.

Exclusion Criteria:

  • type 1 diabetes,
  • recent (within 3 months) cardiovascular event,
  • severe hepatic or renal dysfunction,
  • insulin use,
  • glucocorticoid use.
Both
25 Years to 80 Years
No
Korea, Republic of
 
NCT01051089
2009-459
Not Provided
Moonsuk Nam, MD, PhD, Inha University School of Medicine, Inha University Hospital
Inha University Hospital
Not Provided
Not Provided
Inha University Hospital
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP