Leukocyte Dysfunction in Diabetic Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01144520
Recruitment Status : Active, not recruiting
First Posted : June 15, 2010
Last Update Posted : March 20, 2018
Information provided by (Responsible Party):
Sashwati Roy, Ohio State University

June 14, 2010
June 15, 2010
March 20, 2018
March 2010
December 2018   (Final data collection date for primary outcome measure)
Ex vivo leukocyte function by measuring ROS production [ Time Frame: immediately after blood draw ]
After blood draw monocytes are separated from whole blood and production of oxidants by these cells
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Complete list of historical versions of study NCT01144520 on Archive Site
Ex vivo NADPH oxidase gene and protein expression [ Time Frame: After blood draw ]
Gene and protein expressions are measured using Western blot and real time PCR.
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Leukocyte Dysfunction in Diabetic Patients.
Leukocyte Dysfunction in Diabetic Patients.
The purpose of this study is to study impairment of white blood cell function in patients with type II diabetes.
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.
Observational Model: Other
Time Perspective: Other
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Retention:   Samples With DNA
Non-Probability Sample
Subjects will be recruited from the population who visit the Ohio State University (OSU) Hospitals and Comprehensive Wound Center (CWC), OSU Wexner Medical Center diabetic clinics and Bariatric clinic.
Diabetes Mellitus, Type 2
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  • Normoglycemic
    Healthy subjects that do not have diabetes
  • Type II Diabetes (HbA1c <7 or 7%)
    Subject that have Type II Diabetes with good glucose control with glycated hemoglobin (HbA1c <7 or 7%)
  • Type II Diabetes (HbA1c between 7.1-9)
    Subjects with Type II Diabetes with moderate glucose control (HbA1c between 7.1-9)
  • Type II Diabetes (HbA1c >9%)
    Subjects with Type II Diabetes with poor glucose control (HbA1c >9%)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults ages 40-60 yrs old clinically diagnosed with Type II Diabetes
  • Adults ages 40-60 yrs old without Diabetes

Exclusion Criteria:

  • Unable to provide informed consent
  • Pregnant Females
  • Therapeutically Immuno-compromised
Sexes Eligible for Study: All
40 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Sashwati Roy, Ohio State University
Sashwati Roy
Not Provided
Principal Investigator: Roy Sashwati, MS, PhD Ohio State University Dept of Surgery
Ohio State University
March 2018