Leukocyte Dysfunction in Diabetic Patients.

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Leukocyte Dysfunction in Diabetic Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01144520
• Other study ID #: 2009H0270
• Status: Terminated
• Start date: March 2010
• Est. completion date: December 2018

Study information

• Verified date: November 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Wound Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Sashwati Roy

Country where clinical trial is conducted

United States, 

References & Publications (4)

Hill HR, Sauls HS, Dettloff JL, Quie PG. Impaired leukotactic responsiveness in patients with juvenile diabetes mellitus. Clin Immunol Immunopathol. 1974 Apr;2(3):395-403. — View Citation

Lin X, Candlish JK, Thai AC. Superoxide production by neutrophils from diabetics and normal subjects in response to glucose and galactose. Exp Mol Pathol. 1993 Jun;58(3):229-36. — View Citation

Molenaar DM, Palumbo PJ, Wilson WR, Ritts RE Jr. Leukocyte chemotaxis in diabetic patients and their nondiabetic first-degree relatives. Diabetes. 1976;25(2 SUPPL):880-3. — View Citation

Shurtz-Swirski R, Sela S, Herskovits AT, Shasha SM, Shapiro G, Nasser L, Kristal B. Involvement of peripheral polymorphonuclear leukocytes in oxidative stress and inflammation in type 2 diabetic patients. Diabetes Care. 2001 Jan;24(1):104-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ex vivo leukocyte function by measuring ROS production	After blood draw monocytes are separated from whole blood and production of oxidants by these cells	immediately after blood draw
Secondary	Ex vivo NADPH oxidase gene and protein expression	Gene and protein expressions are measured using Western blot and real time PCR.	After blood draw

External Links

•   OSU Comprehensive Wound Center