Leukocyte Dysfunction in Diabetic Patients.

NCT ID: NCT01144520

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Normoglycemic

Healthy subjects that do not have diabetes

No interventions assigned to this group

Type II Diabetes (HbA1c <7 or 7%)

Subject that have Type II Diabetes with good glucose control with glycated hemoglobin (HbA1c \<7 or 7%)

No interventions assigned to this group

Type II Diabetes (HbA1c between 7.1-9)

Subjects with Type II Diabetes with moderate glucose control (HbA1c between 7.1-9)

No interventions assigned to this group

Type II Diabetes (HbA1c >9%)

Subjects with Type II Diabetes with poor glucose control (HbA1c \>9%)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sashwati Roy

OTHER

Sponsor Role lead

Responsible Party

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Sashwati Roy

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Roy Sashwati, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Dept of Surgery

Locations

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Ohio State University Comprehensive Wound Center

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 11194213 (View on PubMed)

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.

Reference Type RESULT
PMID: 8390941 (View on PubMed)

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.

Reference Type RESULT
PMID: 971792 (View on PubMed)

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.

Reference Type RESULT
PMID: 4826528 (View on PubMed)

Related Links

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Other Identifiers

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2009H0270

Identifier Type: -

Identifier Source: org_study_id