Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT01144520
Status:
TERMINATED
Last Update Posted:
2021-11-22
First Post:
2010-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Leukocyte Dysfunction in Diabetic Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'whyStopped': 'researchers moved to new institution and did not transfer project', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2010-06-14', 'studyFirstSubmitQcDate': '2010-06-14', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ex vivo leukocyte function by measuring ROS production', 'timeFrame': 'immediately after blood draw', 'description': 'After blood draw monocytes are separated from whole blood and production of oxidants by these cells'}], 'secondaryOutcomes': [{'measure': 'Ex vivo NADPH oxidase gene and protein expression', 'timeFrame': 'After blood draw', 'description': 'Gene and protein expressions are measured using Western blot and real time PCR.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '11194213', 'type': 'RESULT', '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.'}, {'pmid': '8390941', 'type': 'RESULT', '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.'}, {'pmid': '971792', 'type': 'RESULT', '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.'}, {'pmid': '4826528', 'type': 'RESULT', '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.'}], 'seeAlsoLinks': [{'url': 'http://medicine.osu.edu/regenerativemedicine/Pages/index.aspx', 'label': 'OSU Center for Regenerative Medicine and Cell Based Therapies'}, {'url': 'http://medicalcenter.osu.edu/patientcare/healthcare_services/wound_care/Pages/index.aspx', 'label': 'OSU Comprehensive Wound Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study impairment of white blood cell function in patients with type II diabetes.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ages 40-60 yrs old clinically diagnosed with Type II Diabetes\n* Adults ages 40-60 yrs old without Diabetes\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Pregnant Females\n* Therapeutically Immuno-compromised'}, 'identificationModule': {'nctId': 'NCT01144520', 'briefTitle': 'Leukocyte Dysfunction in Diabetic Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Leukocyte Dysfunction in Diabetic Patients.', 'orgStudyIdInfo': {'id': '2009H0270'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normoglycemic', 'description': 'Healthy subjects that do not have diabetes'}, {'label': 'Type II Diabetes (HbA1c <7 or 7%)', 'description': 'Subject that have Type II Diabetes with good glucose control with glycated hemoglobin (HbA1c \\<7 or 7%)'}, {'label': 'Type II Diabetes (HbA1c between 7.1-9)', 'description': 'Subjects with Type II Diabetes with moderate glucose control (HbA1c between 7.1-9)'}, {'label': 'Type II Diabetes (HbA1c >9%)', 'description': 'Subjects with Type II Diabetes with poor glucose control (HbA1c \\>9%)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Wound Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Roy Sashwati, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Dept of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sashwati Roy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sashwati Roy', 'investigatorAffiliation': 'Ohio State University'}}}}