Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02612493
Status:
COMPLETED
Last Update Posted:
2015-11-23
First Post:
2015-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obesity and Metabolic Surgery in Patients With Type I Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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': 'D001836', 'term': 'Body Weight Changes'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-20', 'studyFirstSubmitDate': '2015-11-17', 'studyFirstSubmitQcDate': '2015-11-20', 'lastUpdatePostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin dosage', 'timeFrame': 'up to 8 years', 'description': 'Insulin dosage postsurgery'}], 'secondaryOutcomes': [{'measure': 'Excess Weight loss in %', 'timeFrame': 'up to 8 years'}, {'measure': 'Change in HgA1c', 'timeFrame': 'up to 8 years'}, {'measure': 'Change in lipids', 'timeFrame': 'up to 8 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obesity surgery', 'type I diabetes', 'weight loss', 'insulin dosage', 'postsurgery metabolic changes'], 'conditions': ['Type I Diabetes']}, 'referencesModule': {'references': [{'pmid': '23834044', 'type': 'RESULT', 'citation': 'Raab H, Weiner RA, Frenken M, Rett K, Weiner S. Obesity and metabolic surgery in type 1 diabetes mellitus. Nutr Hosp. 2013 Mar;28 Suppl 2:31-4. doi: 10.3305/nh.2013.28.sup2.6711.'}, {'pmid': '25342846', 'type': 'RESULT', 'citation': 'Kirwan JP, Brethauer SA, Aminian A, Rosenthal RJ, Kashyap SR, Schauer PR. Response to comments on Brethauer et al. Bariatric surgery improves the metabolic profile of morbidly obese patients with type 1 diabetes. Diabetes care 2014;37:e51-e52. Diabetes Care. 2014 Nov;37(11):e251. doi: 10.2337/dc14-1769. No abstract available.'}, {'pmid': '24558084', 'type': 'RESULT', 'citation': 'Brethauer SA, Aminian A, Rosenthal RJ, Kirwan JP, Kashyap SR, Schauer PR. Bariatric surgery improves the metabolic profile of morbidly obese patients with type 1 diabetes. Diabetes Care. 2014;37(3):e51-2. doi: 10.2337/dc13-1736. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Obesity is the indication for bariatric surgery in type I diabetes. Interestingly postsurgery the patients improve remarkable in their need for insulin, not only in the daily total insulin dosage but also in the dosage of IU per kg.', 'detailedDescription': 'The investigators performed a retrospective analysis on 16 patients undergoing weight loss surgery in obesity with concomitant type I diabetes. All patients were evaluated during Follow - Up to analyze insulin dosage and metabolic changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All obeses patients with type I diabetes who underwent weight loss surgery in our department.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type I diabetes\n* BMI \\> 40kg/m2\n\nExclusion Criteria:\n\n* type II diabetes'}, 'identificationModule': {'nctId': 'NCT02612493', 'briefTitle': 'Obesity and Metabolic Surgery in Patients With Type I Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Sana Klinikum Offenbach'}, 'officialTitle': 'Obesity and Metabolic Surgery in Patients With Type I Diabetes', 'orgStudyIdInfo': {'id': 'FF 120/2015'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Obese patients with type I diabetes', 'type': 'OTHER', 'description': 'Postsurgical follow - up in obese patients with type I diabetes'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rudolf Weiner, MD, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Sana Klinikum Offenbach'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sana Klinikum Offenbach', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Christine Stier', 'investigatorAffiliation': 'Sana Klinikum Offenbach'}}}}