Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT01358994
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2011-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin Treatment, Renal Function and Lactic Acidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D000140', 'term': 'Acidosis, Lactic'}], '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'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-06', 'studyFirstSubmitDate': '2011-05-19', 'studyFirstSubmitQcDate': '2011-05-20', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metformin', 'type 2 diabetes', 'e-GFR', 'creatinine', 'lactic acidosis'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'From a central registry at the National Board of Health and Welfare in Sweden collect all patients in the city of Malmö prescribed metformin during two years. Glomerular filtration rate (eGFR) was estimated from the CKD-EPI formula (n=5408) and compared to a control material (n=2815) from the same town. All cases of severe lactic acidosis rendering ICU admission were also sought. The study hypothesis is that metformin is prescribed to patients with lower GFR than anticipated with very few cases of lactic acidosis registered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients irrespective of age prescribed metformin according to a registry for the city of Malmö', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in the city of Malmö prescribed metformin at least three times during two years\n* Available at least one p-creatinine during the two years\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01358994', 'briefTitle': 'Metformin Treatment, Renal Function and Lactic Acidosis', 'organization': {'class': 'OTHER', 'fullName': 'Skane University Hospital'}, 'officialTitle': 'Metformin Treatment, Renal Function and Lactic Acidosis. A Population Based', 'orgStudyIdInfo': {'id': 'Metformin02'}}, 'contactsLocationsModule': {'locations': [{'zip': 'SE 20502', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Dept of Nephrology', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skane University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Gunnar Sterner', 'investigatorAffiliation': 'Skane University Hospital'}}}}