Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-02-24 @ 8:48 AM
Study NCT ID:
NCT01889706
Status:
UNKNOWN
Last Update Posted:
2013-06-28
First Post:
2013-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin Therapy in Type 1 Diabetes Mellitus.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009765', 'term': 'Obesity'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-26', 'studyFirstSubmitDate': '2013-06-25', 'studyFirstSubmitQcDate': '2013-06-26', 'lastUpdatePostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of skin AGE', 'timeFrame': '6 months', 'description': 'AGE-Reader ( Diagn-Optic)'}], 'primaryOutcomes': [{'measure': 'Body fat content and anthropometric parameters', 'timeFrame': '6 months', 'description': 'assessed by electrical bioimpedance using a Tanita BC-418 MA device,'}], 'secondaryOutcomes': [{'measure': 'Assessment of metabolic control', 'timeFrame': '6 months', 'description': '(HbA1C, lipid profile)'}, {'measure': 'Insulin requirement', 'timeFrame': '3 , 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 1 diabetes mellitus,', 'metformin,', 'insulin resistance,', 'obesity'], 'conditions': ['Loss of Control of Diabetes']}, 'descriptionModule': {'briefSummary': 'The use of exogenous insulin and incorrect nutritional habits are conducive to obesity and excess weight. This leads to the development of insulin resistance, even in patients with type 1 diabetes mellitus. The purpose of this study is to assess the effects of metformin as adjunctive therapy on anthropometric parameters, insulin resistance and metabolic control in overweight and obese patients with type 1 diabetes mellitus.\n\nThe study group consists of 200 Caucasian type 1 diabetic patients with elevated adipose tissue content as measured by electrical bioimpedance, treated at the Poznan University of Medical Sciences Department of Diabetology in 2009-2014. All patients have type 1 diabetes diagnosed by autoimmune antibodies, and are treated with intensive insulin therapy. This group is divided into metformin treated arm (group I+ M, 100 subjects), the remaining 100 patients are treated with insulin alone (control group, group I). Metformin is administered at least 6 months at a mean dose of 1000 mg/day.\n\nThe investigators would like to assess the impact of metformin treatment on metabolic control, insulin resistance and anthropometric parameters in overweight and obese patients with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '200 Caucasian patients with type 1 diabetes admitted to the Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences in years 2009-2014, treated with intensive insulintherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years \\<60 years,\n* duration of diabetes \\>3 years,\n* lack of metabolic control- HbA1C\\>7,5% (despite participation in 5-day WHO education program)\n* treated with intensive insulin therapy\n\nExclusion Criteria:\n\n* metabolically decompensate diabetes with acetonuria,\n* suspected lack of compliance,\n* lack of glucose and ketones self-monitoring,\n* hypoglycaemic unawareness or recurrent severe hypoglycemia (defined as more than two episodes of hypoglycemia lowered than 60 mg/dl with loss of consciousness, required assistance to treat) in the past 3 months,\n* recurrent diabetic ketoacidosis (more than two episodes in the past year)\n* another serious medical illness,\n* pregnancy or sexually active woman unwilling to take birth control.\n* renal impairment (estimated on the value calculated glomerular filtration rate using the MDRD formula-estimated glomerular filtration rate, eGFR\\<45 mL / min\n* liver cell damage Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) greater than twice the upper normal limit),\n* history of drug or alcohol abuse or those who used this drug before\n* changes in the way of antihypertensive and antihyperlipemic treatment.'}, 'identificationModule': {'nctId': 'NCT01889706', 'briefTitle': 'Metformin Therapy in Type 1 Diabetes Mellitus.', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Application of Metformin as Adjuvant Therapy in Overweight and Obese Patients With Type 1 Diabetes Mellitus.', 'orgStudyIdInfo': {'id': 'MTiT1DM'}}, 'contactsLocationsModule': {'locations': [{'zip': '60-834', 'city': 'Poznan', 'state': 'Great Poland', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Agnieszka Zawada, MD', 'role': 'CONTACT', 'email': 'aga.zawada@gmail.com'}], 'facility': 'Department of Internal Medicine and Diabetology, Raszeja Hospital', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Dariusz Naskręt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poznań University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Agnieszka Zawada', 'investigatorAffiliation': 'Poznan University of Medical Sciences'}}}}