Leukocyte Dysfunction in Diabetic Patients.

Terminated

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT01144520
• Lead Sponsor: Sashwati Roy

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-14
• Study First Posted: 2010-06-15
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ex vivo leukocyte function by measuring ROS production	immediately after blood draw	After blood draw monocytes are separated from whole blood and production of oxidants by these cells

Secondary Outcome Measures

Name	Time	Method
Ex vivo NADPH oxidase gene and protein expression	After blood draw	Gene and protein expressions are measured using Western blot and real time PCR.

Trial Locations

Locations (1)

Ohio State University Comprehensive Wound Center; 🇺🇸 Columbus, Ohio, United States