Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-03-29 @ 6:43 AM
Study NCT ID:
NCT02417103
Status:
TERMINATED
Last Update Posted:
2022-06-30
First Post:
2015-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pretreatment of Patients Expecting Bariatric Surgery With the GLP-1 Analogon Liraglutid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-05-25', 'releaseDate': '2022-07-14'}], 'estimatedResultsFirstSubmitDate': '2022-07-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Recruiting failure', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2015-04-14', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight reduction', 'timeFrame': '4 years', 'description': 'to compare body weight with type 2 Diabetes scheduled for weight loss surgery after 8 weeks of preoperative treatment with either placebo or liragludite'}], 'secondaryOutcomes': [{'measure': 'GLP-1 Levels', 'timeFrame': '4 years', 'description': 'Measurement of GLP-1 levels during the defined period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon Liraglutide on the lipid metabolism an inflammation in adipose tissue.', 'detailedDescription': 'The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon Liraglutide on the lipid metabolism an inflammation in adipose tissue. As GLP-1 is presumed to improve insulin sensitivity and associated parameters the investigators hypothesize that this might be due to changes in lipid metabolism which might be involved in the regulation of insulin sensitivity. Therefore the investigators intend to investigate changes of metabolic pathways before and after treatment with the GLP-1 analog liraglutide that could play a crucial role in pathogenesis as well as regulation of insulin sensitivity and atherogenic dyslipidemia such as: de novo lipogenesis and reverse cholesterol transport'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 35-55 Kg/m2\n* Fasting Blood glucose \\>140mg/dl\n* Planned bariatric surgery\n* Diabetic Medication (Metformin, Sulfonylurea, Insuline)\n\nExclusion Criteria:\n\n* Known hypersensitivity against Liraglutid\n* Pretreatment DPP-4 Inhibitors or GLP-1 Analogue the last 3 months\n* HbA1c \\>10%'}, 'identificationModule': {'nctId': 'NCT02417103', 'briefTitle': 'Pretreatment of Patients Expecting Bariatric Surgery With the GLP-1 Analogon Liraglutid', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Pretreatment of Patients Expecting Bariatric Surgery With the GLP-1 Analogon', 'orgStudyIdInfo': {'id': 'GLP1Bariatric'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GLP-1 (Liraglutide)', 'description': 'Daily subcutaneous injection of Lirglutide over 9 weeks prior to bariatric surgery with a dosing of 0,6-1,8 mg', 'interventionNames': ['Drug: GLP-1 (Liraglutide)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'description': 'Daily subcutaneous injection of PL1/PR1 Placebo over 9 weeks prior to bariatric surgery with a dosing of 0,6-1,8 mg', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GLP-1 (Liraglutide)', 'type': 'DRUG', 'otherNames': ['Victoza'], 'description': 'GLP-1 Analogon', 'armGroupLabels': ['GLP-1 (Liraglutide)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['PL1 PR1'], 'description': 'Placebo', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Jens Aberle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-07-14', 'type': 'RELEASE'}, {'date': '2023-05-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Universitätsklinikum Hamburg-Eppendorf'}}}}