Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT00767351
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2008-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Variation in Serum Levels of Metformin in Patients With Reduced Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Sweden']}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-06', 'studyFirstSubmitDate': '2008-10-06', 'studyFirstSubmitQcDate': '2008-10-06', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2', 'Metformin', 'Pharmacokinetics']}, 'referencesModule': {'references': [{'pmid': '20215446', 'type': 'DERIVED', 'citation': 'Frid A, Sterner GN, Londahl M, Wiklander C, Cato A, Vinge E, Andersson A. Novel assay of metformin levels in patients with type 2 diabetes and varying levels of renal function: clinical recommendations. Diabetes Care. 2010 Jun;33(6):1291-3. doi: 10.2337/dc09-1284. Epub 2010 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'Metformin is widely used for treatment of type 2 diabetes mellitus. Side-effects are few and mainly from the gastrointestinal tract. Since metformin is cleared from the blood exclusively via the kidneys reduced renal function is a relative contraindication. We have earlier demonstrated that metformin safely can be used to a lower GFR level of 30 ml/min/1.73. Below that level the risk of lactacidosis, a severe complication, increases.\n\nIn the present study we plan to analyse serum levels of metformin repeatedly in patients with moderate renal failure (CKD = GFR of 30-60 ml/min/1.73). Blood samples will be taken as trough values in the morning, week 0, 2, 4, and 8 and at four weeks a blood sample will be taken two hours after intake of the morning dose of metformin. Renal function will be estimated with creatinine and cystatin C at each occasion. The intraindividual variation of metformin will be calculated.\n\nThe study rests on a new method for measuring metformin. The technique uses Liquid Chromatography Tandem Mass Spectometry (LCMSMS). Proteins are removed from serum by adding acetonitrile to the sample. After centrifugation a diluted portion of the supernatant is injected into the LCMSMS-system. The total runtime for a sample is 6 minutes.\n\nThe study will show if variation in serum levels of metformin measured in the same patient is high or low and thus give us better understanding whether a change i serum level is due to biological variation or to increased retention caused by progressive renal failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 2 DM followed at the out-patient department at the hospital will be asked to join the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients above the age of 18 years with type 2 diabetes mellitus.\n* Reduced renal function measured as estimated GFR (below 60 ml/min/1.73).\n* Treatment with metformin on going.\n\nExclusion Criteria:\n\n* Severely reduced GFR (\\< 30 ml(min/1.73)'}, 'identificationModule': {'nctId': 'NCT00767351', 'briefTitle': 'Variation in Serum Levels of Metformin in Patients With Reduced Renal Function', 'organization': {'class': 'OTHER', 'fullName': 'Skane University Hospital'}, 'officialTitle': 'Intraindividual Variation of Serum Metformin in a Cohort of Patients With Type 2 DM and Moderately Reduced Renal Function', 'orgStudyIdInfo': {'id': '001'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skane University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Gunnar Sterner', 'investigatorAffiliation': 'Skane University Hospital'}}}}