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

Tracking Information
First Received Date ^ICMJE	January 15, 2010
Last Updated Date	January 15, 2010
Start Date ^ICMJE	June 2009
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 15, 2010)	HbA1c, serum adipokine levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: January 15, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Lifestyle Modification on Metabolic Parameters in Type 2 Diabetic Patients
Official Title ^ICMJE	Effects of Lifestyle Modification Focusing on Exercise Intervention on Risk of Atherosclerosis and Metabolic Parameters in Type 2 Diabetic Patients
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Type 2 Diabetes Mellitus
Intervention ^ICMJE	Behavioral: Lifestyle modification Exercise and diet education
Study Arm (s)	Experimental: Lifestyle modification supervised exercise with diet education Intervention: Behavioral: Lifestyle modification No Intervention: Control Control (ordinary care with usual education)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	December 2010
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	25 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Listed Location Countries ^ICMJE	Korea, Republic of
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT01051089
Other Study ID Numbers ^ICMJE	2009-459
Has Data Monitoring Committee	Not Provided
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Moonsuk Nam, MD, PhD, Inha University School of Medicine, Inha University Hospital
Study Sponsor ^ICMJE	Inha University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Inha University Hospital
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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