Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2026-01-18 @ 12:05 AM
Study NCT ID:
NCT01403961
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2011-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1760}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-09', 'studyFirstSubmitDate': '2011-07-26', 'studyFirstSubmitQcDate': '2011-07-26', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare incidence of immediate post surgery complications in diabetic patients with HbA1c > 7 and patients with HbA1c ≤ 7', 'timeFrame': '30 days postsurgery', 'description': 'Incidence of death, infections, cardiovascular o brainvascular disease'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate Hemoglobin A1c values previous to a surgery in patients with diabetes type II and the complication incidence in immediate post surgery.', 'detailedDescription': 'The diabetes is a highly prevalent disease in patients who undergo an evaluation previous to a surgery. The most efficient glucose control, in patients with diabetes type II, reduces the risk of microvascular complications. Diabectic patients who underwent scheduled cardivacular or noncardiovascular surgeries show an increase rate of immediate and long-term complications. The most frequent complications are infections, cardiovascular events and death.\n\nIntensive insulinisation during cardiovascular surgery reduces the risk of a new coronary event in the immediate post surgery. No studies have been found that show the evaluation of Hemoglobin A1c values before the surgery and the immediate post surgery complications.\n\nA poor glycemic control has been associated to a large number of chronic complications like diabetic neuropathy, nephropathy, retinopathy and infection disease. The Hemoglobin A1c is used like a marker of the glycemic control in the last 120 days and has a correlation with the no enzyme glicosilation. This marker could have a relation with the complication after the programmed surgery.\n\nThis study will evaluate the incidence of complications in the immediate post operatory in patients with diabetes type II in relation to the hemoglobin A1c before the surgery. If the hemoglobin A1c has a correlation with the incidence of cardiovascular complications, this could mark a change in the therapeutic measures prior the programmed surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult diabetic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Patients older than 18 years with diagnosed of diabetes type 2\n2. Programmed major surgery with expected hospitalization longer than 24 hours\n\nExclusion Criteria\n\n1. Refusal to participate in the study or the informed consent process.\n2. Programmed cardiac or coronary surgery\n3. Technical complications inherent to surgical or anatomical abnormalities.\n4. Pregnant women.\n5. Active infection prior to performing surgery'}, 'identificationModule': {'nctId': 'NCT01403961', 'acronym': 'HbA1c', 'briefTitle': 'Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': 'Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2 (HbA1c)', 'orgStudyIdInfo': {'id': '1439'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HbA1c > 7', 'description': 'Diabetic patients with HbA1c \\> 7'}, {'label': 'HbA1c ≤ 7', 'description': 'Diabetic patients with HbA1c ≤ 7'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1181ACH', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Diego Giunta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AIMI. HIBA.'}, {'name': 'Javier GIunta, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HIBA'}, {'name': 'Carlos Bonofiglio, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'HIBA'}, {'name': 'Leon Litwak, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'HIBA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Diego Hernan Giunta, MD', 'investigatorAffiliation': 'Hospital Italiano de Buenos Aires'}}}}