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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 : Unknown
Verified March 2018 by Sashwati Roy, Ohio State University.
Recruitment status was:  Active, not recruiting
First Posted : June 15, 2010
Last Update Posted : March 20, 2018
Information provided by (Responsible Party):
Sashwati Roy, Ohio State University

Brief Summary:
The purpose of this study is to study impairment of white blood cell function in patients with type II diabetes.

Condition or disease
Diabetes Mellitus, Type 2

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 : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Other
Official Title: Leukocyte Dysfunction in Diabetic Patients.
Study Start Date : March 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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%)

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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), OSU Wexner Medical Center diabetic clinics and Bariatric clinic.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01144520

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United States, Ohio
Ohio State University Comprehensive Wound Center
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Sashwati Roy
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Principal Investigator: Roy Sashwati, MS, PhD Ohio State University Dept of Surgery
Additional Information:
Publications of Results:
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Responsible Party: Sashwati Roy, Associate Professor, Ohio State University Identifier: NCT01144520    
Other Study ID Numbers: 2009H0270
First Posted: June 15, 2010    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases