Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT01634035
Status:
COMPLETED
Last Update Posted:
2012-07-06
First Post:
2010-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Glycated Hemoglobin and Mean Plasma Glucose in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'review of previous blood tests'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-02', 'studyFirstSubmitDate': '2010-06-03', 'studyFirstSubmitQcDate': '2012-07-02', 'lastUpdatePostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure levels of plasma blood glucose and HbA1c', 'timeFrame': '6 month intervals'}], 'secondaryOutcomes': [{'measure': 'Measure ferritin, erythropoetin dose, reticulocytes count', 'timeFrame': '6 month intervals'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glycated hemoglobin', 'mean plasma glucose'], 'conditions': ['ESRD']}, 'descriptionModule': {'briefSummary': 'The investigators are studying the correlation between Hba1c and the mean plasma glucose in diabetic hemodialysis patients.We are reviewing if HbA1c is a good clinical tool to assess glycemic control over a 3 months duration in hemodialysis patients', 'detailedDescription': 'The Hb turnover in hemodialysis population is higher than the general population leading to a general believe that HbA1c tend to underestimate mean plasma glucose.\n\nThe investigators are trying to define the correlation between mean plasma glucose and HbA1c in the hemodialysis population and trying to study the factors that could affect this correlation (dose of erythropoetin, ret count..) We are trying to see if HbA1c is a better tool to assess glycemic control over 1 month than glycemic control over 3 month.\n\nThis clinicaly will translate in obtaining HbA1c more frequently in hemodialysis patients to assess their glycemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all hemodialysis and diabetic population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18\n* Hemodialysis and diabetic\n* Lab data are available for more than 6 months\n\nExclusion Criteria:\n\n* Lab data not available'}, 'identificationModule': {'nctId': 'NCT01634035', 'briefTitle': 'Correlation Between Glycated Hemoglobin and Mean Plasma Glucose in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Correlation Between Glycated Hemoglobin and Mean Plasma Glucose in Hemodialysis Patients.', 'orgStudyIdInfo': {'id': '09-001'}, 'secondaryIdInfos': [{'id': '09-001', 'type': 'OTHER_GRANT', 'domain': 'SIUH IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'diabetic hemodialysis', 'description': 'all patient diabetic and on hemodialysis were involved if they are on hemodialysis for more than 3 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Staten Island University Hospital', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}], 'overallOfficials': [{'name': 'suzanne el-sayegh, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'statenisland university hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}