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Effects of Lifestyle Modification on Metabolic Parameters in Type 2 Diabetic Patients
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Inha University Hospital.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Inha University Hospital
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 |
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 Provided | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 | ||
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* 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 | ||
| Estimated 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 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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