Leukocyte Dysfunction in Diabetic Patients.

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sashwati Roy, The Ohio State University
ClinicalTrials.gov Identifier:
First received: June 14, 2010
Last updated: January 23, 2015
Last verified: January 2015
The purpose of this study is to study impairment of white blood cell function in patients with type II diabetes.

Diabetes Mellitus, Type 2

Study Type: Observational
Official Title: Leukocyte Dysfunction in Diabetic Patients.

Resource links provided by NLM:

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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.

Biospecimen Retention:   Samples With DNA

Estimated Enrollment: 200
Study Start Date: March 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
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%)

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.

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01144520

United States, Ohio
Ohio State University Comprehensive Wound Center
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Sashwati Roy
Principal Investigator: Roy Sashwati, MS, PhD Ohio State University Dept of Surgery