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
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01051089
Other Study ID Numbers ^ICMJE	2009-459
Has Data Monitoring Committee	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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