Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-03-03 @ 7:39 PM
Study NCT ID:
NCT02220257
Status:
UNKNOWN
Last Update Posted:
2014-08-19
First Post:
2014-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Partial Remission Phase of Type 1 Diabetes on Patient Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-18', 'studyFirstSubmitDate': '2014-08-15', 'studyFirstSubmitQcDate': '2014-08-18', 'lastUpdatePostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of chronic complication of diabetes (retinopathy or neuropathy or nephropathy)', 'timeFrame': 'Evaluation for chronic complications of diabetes was conducted after a period of no less than 5 years from diagnosis.'}]}, 'conditionsModule': {'keywords': ['diabetes mellitus type 1', 'remission, honeymoon', 'microangiopathy'], 'conditions': ['Diabetes Mellitus Type 1', 'Remission of Type 1 Diabetes', 'Chronic Complications of Diabetes']}, 'descriptionModule': {'briefSummary': 'Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets of Langerhans in the pancreas. Symptoms of diabetes present when the mass of insulin-producing cells reaches a point where insulin concentration does not suffice to maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of diabetes and initiation of insulin therapy. This phenomenon is called a remission.\n\nThe aim of this study is to asses the influence of occurrence and duration of remission on development of chronic complications of diabetes and patients outcome.', 'detailedDescription': 'Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets of Langerhans in the pancreas. Symptoms of diabetes present when the mass of insulin-producing cells reaches a point where insulin concentration does not suffice to maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of diabetes and initiation of insulin therapy. This phenomenon is called a remission.\n\nThe aim of this study is to asses influence of occurrence and duration of remission on development of chronic complications of diabetes and patients outcome.\n\nClinical remission was defined as time in which all of the following criteria were met: HbA1c below 6.5 % , dose of exogenous insulin below 0.3 U / kg body weight and serum C-peptide concentration above 0.5 ng / ml. Patients were divided into those who were in remission at any time during follow-up (remitters) and non-remitters.\n\nAt follow-up occurrence of chronic microvascular complications of diabetes (retinopathy, diabetic kidney disease and neuropathy) was evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study included 240 consecutive patients, including 77 women and 143 men hospitalized at the Department of Internal Medicine and Diabetology of Poznan University of Medical Sciences between 2004 and 2007 due to newly diagnosed type 1 diabetes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed type 1 diabetes according to ADA (American Diabetes Association) 1997 criteria.\n2. Age 18-35 years\n3. Education with regard to intensive functional insulin therapy at the time of diagnosis\n4. Patient consent to participation in the study\n\nExclusion Criteria:\n\n1. Acute inflammation (serum C-reactive protein concentration (hsCRP) \\>10mg/L, leukocytosis \\>15x109/L, erythrocyte sedimentation rate (OB) \\>30 mm/h)\n2. Laboratory signs of liver damage: alanine and aspartate aminotransferase elevated 2-fold over the upper limit of normal range\n3. History of other chronic diseases (e.g. asthma, neoplastic diseases, liver cirrhosis)\n4. Other autoimmunological diseases other than diabetes\n5. Not confirming type 1 diabetes after obtaining results of autoantibodies'}, 'identificationModule': {'nctId': 'NCT02220257', 'acronym': 'POZREM', 'briefTitle': 'The Influence of Partial Remission Phase of Type 1 Diabetes on Patient Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Influence of Occurrence of Remission and Its Duration on Development of Chronic Complications of Type 1 Diabetes and Patient Outcome', 'orgStudyIdInfo': {'id': 'REMISSIONDM1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Newly diagnosed type 1 diabetes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60-834', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'country': 'Poland', 'facility': 'Franciszek Raszeja Hospital; Poznan University of Medical Science', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Paweł Niedźwiecki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poznan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Paweł Niedźwiecki', 'investigatorFullName': 'Paweł Niedźwiecki', 'investigatorAffiliation': 'Poznan University of Medical Sciences'}}}}