Leukocyte Dysfunction in Diabetic Patients.
| Tracking Information | |||||
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| First Received Date ICMJE | June 14, 2010 | ||||
| Last Updated Date | May 16, 2013 | ||||
| Start Date ICMJE | March 2010 | ||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Ex vivo leukocyte function by measuring ROS production [ Time Frame: immediately after blood draw ] [ Designated as safety issue: No ] After blood draw monocytes are separated from whole blood and production of oxidants by these cells |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01144520 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Ex vivo NADPH oxidase gene and protein expression [ Time Frame: After blood draw ] [ Designated as safety issue: No ] Gene and protein expressions are measured using Western blot and real time PCR. |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Leukocyte Dysfunction in Diabetic Patients. | ||||
| Official Title ICMJE | Leukocyte Dysfunction in Diabetic Patients. | ||||
| Brief Summary | The purpose of this study is to study impairment of white blood cell function in patients with type II diabetes. |
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| Detailed Description | Leucocytes from poorly controlled diabetes exhibit aberrant chemotaxis, increased susceptibility to bacterial infection, leukotriene production, lysosomal enzyme release, proinflammatory cytokine expression and production of reactive oxygen species. Aberrant glucose concentration in diabetics affects functions of peripheral blood system as well as the immune system leading to impaired host defense. Impaired wound healing is a serious complication associated with diabetes. We hypothesized that impairment in leukocyte function results in dysfunctional inflammatory response in diabetic wounds. The proposed studies focus on characterizing mechanisms that will improve our understanding of the dysfunctional inflammatory response resulting in non-healing chronic wounds in diabetics. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Blood |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Subjects will be recruited from the population who visit the Ohio State University (OSU) Hospitals and Comprehensive Wound Center (CWC), OSUMC diabetic clinics and Bariatric clinic. |
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| Condition ICMJE | Diabetes Mellitus, Type 2 | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | August 2014 | ||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01144520 | ||||
| Other Study ID Numbers ICMJE | 2009H0270 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sashwati Roy, The Ohio State University | ||||
| Study Sponsor ICMJE | Sashwati Roy | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Ohio State University | ||||
| Verification Date | May 2013 | ||||
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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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