Effects of Lifestyle Modification on Metabolic Parameters in Type 2 Diabetic Patients
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ClinicalTrials.gov Identifier: NCT01051089 |
Recruitment Status
: Unknown
Verified January 2010 by Inha University Hospital.
Recruitment status was: Recruiting
First Posted
: January 18, 2010
Last Update Posted
: January 18, 2010
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Sponsor:
Inha University Hospital
Information provided by:
Inha University Hospital
Tracking Information | |||
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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 |
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 |
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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 |
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Condition ICMJE | Type 2 Diabetes Mellitus | ||
Intervention ICMJE | Behavioral: Lifestyle modification
Exercise and diet education |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Unknown status | ||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 25 Years to 80 Years (Adult, Senior) | ||
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 |