Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-19 @ 3:33 PM
Study NCT ID:
NCT01937858
Status:
TERMINATED
Last Update Posted:
2020-02-20
First Post:
2013-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation Between HbA1c and Mean Blood Glucose in Patients With Diabetes and Renal Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Saudi Arabia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2013-09-04', 'studyFirstSubmitQcDate': '2013-09-04', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation', 'timeFrame': 'three months', 'description': 'The quantitative correlation between mean blood glucose and HbA1c in patients with diabetes and renal failure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HbA1c', 'glycated hemoglobin', 'correlation', 'diabetes', 'renal failure'], 'conditions': ['Diabetes', 'Renal Failure']}, 'descriptionModule': {'briefSummary': 'The value of HbA1c as a tool to determine glycemic control in patients with diabetes and renal failure has not been well studied, the same accepted normal ranges for HbA1c are applied to all patients with diabetes regardless of their renal function. We would like to evaluate the use of HbA1c as a tool of assessing long term glycemic control in this subgroup of patients with diabetes and evaluate the effect of dialysis on HbA1c'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Our target population is patients with diabetes and impaired renal function. This study will include 80 adult patients with type1 or type 2 diabetes; 20 with normal serum creatinine, 40 with renal failure in the predialysis stage (20 with stage 3 and 4 CKD \\[GFR 0f 20-40\\] and 20 with stage 5 CKD not yet on hemodialysis \\[GFR \\<20\\]), and 20 on hemodialysis. All patients should be comfortable and committed to doing self-glucose monitoring.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients \\>18 years of age with type 1 or 2 diabetes who show competence in home glucose monitoring and are willing to commit to doing the testing\n\nExclusion Criteria:\n\n* Pregnancy\n* Having received a blood transfusion with in the preceding three months\n* Known to have any hereditary or hemolytic anemia\n* On a medication known to interfere with HbA1c assay (opiates, acetaminophen, vitamin C, vitamin E) - we will allow patients to be on asprin as almost all patients with diabetes are on this drug.\n* Having a blood hemoglobin \\<7 mg/dl\n* Bilirubin level \\>20mg/dL or a triglyceride level \\> 250mg/dL\n* Alcohol addiction'}, 'identificationModule': {'nctId': 'NCT01937858', 'briefTitle': 'The Correlation Between HbA1c and Mean Blood Glucose in Patients With Diabetes and Renal Failure', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah International Medical Research Center'}, 'officialTitle': 'The Correlation Between HbA1c and Mean Blood Glucose in Patients With Diabetes and Renal Failure', 'orgStudyIdInfo': {'id': 'RC08/107/A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal renal function'}, {'label': 'Stage 2 and 4 and 5 chronic kidney disease'}, {'label': 'End stage renal disease on hemodialysis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reem Mohammad Alamoudi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant Endocrinology', 'investigatorFullName': 'Reem Mohammad Alamoudi', 'investigatorAffiliation': 'King Abdullah International Medical Research Center'}}}}