Leukocyte Dysfunction in Diabetic Patients.

NCT01144520 | Terminated

• 1 other identifier: 2009H0270
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ex vivo NADPH oxidase gene and protein expression

  After blood draw

Study Arms (4)

Normoglycemic

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%)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Adults ages 40-60 yrs old clinically diagnosed with Type II Diabetes
• Adults ages 40-60 yrs old without Diabetes

You may not qualify if:

• Unable to provide informed consent
• Pregnant Females
• Therapeutically Immuno-compromised

Sponsors & Collaborators

• Sashwati Roy: lead

Study Sites (1)

Ohio State University Comprehensive Wound Center

Columbus, Ohio, 43221, United States

Location

Related Publications (4)

• 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.

  PMID: 11194213 RESULT

• 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.

  PMID: 8390941 RESULT

• 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.

  PMID: 971792 RESULT

• 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.

  PMID: 4826528 RESULT

Related Links

• OSU Center for Regenerative Medicine and Cell Based Therapies
• OSU Comprehensive Wound Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Roy Sashwati, MS, PhD

  Ohio State University Dept of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 15, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 22, 2021

Record last verified: 2021-11

Locations

US (1)