Clinical trial NCT01144520: Leukocyte Dysfunction in Diabetic Patients.
Official title: Leukocyte Dysfunction in Diabetic Patients.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2010-06-15
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ex vivo leukocyte function by measuring ROS production
timeFrame: immediately after blood draw
Secondary outcomes:
measure: Ex vivo NADPH oxidase gene and protein expression
timeFrame: After blood draw
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Wound Center
state: Ohio
Study officials:
affiliation: Ohio State University Dept of Surgery
name: Roy Sashwati, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.2337/diacare.24.1.104.
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. doi: 10.1006/exmp.1993.1020.
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.
citation: 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. doi: 10.1016/0090-1229(74)90057-9. No abstract available.