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

Tracking Information
First Submitted Date ICMJE	January 15, 2010
First Posted Date ICMJE	January 18, 2010
Last Update Posted Date	January 18, 2010
Study 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 ]
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 ]; Pulse wave velocity [ Time Frame: 3 months ]; Insulin secretion and sensitivity [ Time Frame: 3 months ]; VO2max [ Time Frame: 3 months ]
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 Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Type 2 Diabetes Mellitus
Intervention ICMJE	Behavioral: Lifestyle modification; Exercise and diet education
Study Arms	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	Unknown status
Estimated Enrollment ICMJE; (submitted: January 15, 2010)	60
Original Estimated Enrollment ICMJE	Same as current
Estimated Study 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	25 Years to 80 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	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