Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-25 @ 2:43 AM
Study NCT ID:
NCT02616003
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2015-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Condition in Giant Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-21', 'studyFirstSubmitDate': '2015-11-17', 'studyFirstSubmitQcDate': '2015-11-24', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operability', 'timeFrame': '21 days', 'description': 'Operability means that weight loss surgery could be performed after preoperative condition (due to less visceral fat, less liver volume)'}], 'secondaryOutcomes': [{'measure': 'Chronic inflammation', 'timeFrame': '21 days', 'description': 'Changing in CRP in g/l during intervention'}, {'measure': 'Chronic inflammation II', 'timeFrame': '21 days', 'description': 'Changing in white blood cell count /nl during intervention'}, {'measure': 'Liver volume', 'timeFrame': '21 days', 'description': 'Changing of liver volume during intervention measured by ultrasound'}, {'measure': 'Liver function', 'timeFrame': '21 days', 'description': 'Changing of GOT in U/l, GPT in U/l, GGT in U/l and AP in U/l'}, {'measure': 'Pulmonary function', 'timeFrame': '21 days', 'description': 'Changing in FEV1 in lung function testing during intervention'}, {'measure': 'Hg A1c in %', 'timeFrame': '21 days'}, {'measure': 'Total Protein in g/l', 'timeFrame': '21 days'}, {'measure': 'Preoperative excess weight loss in %', 'timeFrame': '21 days'}, {'measure': 'Albumin in g/l', 'timeFrame': '21 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Morbid Obesity', 'Giant Obese', 'Preoperative Procedure', 'Liraglutide', 'Leucine'], 'conditions': ['Morbid Obesity', 'Bariatric Surgery Candidate']}, 'referencesModule': {'references': [{'pmid': '25202976', 'type': 'RESULT', 'citation': 'Baggio LL, Drucker DJ. Glucagon-like peptide-1 receptors in the brain: controlling food intake and body weight. J Clin Invest. 2014 Oct;124(10):4223-6. doi: 10.1172/JCI78371. Epub 2014 Sep 9.'}, {'pmid': '24681814', 'type': 'RESULT', 'citation': 'Alhadeff AL, Baird JP, Swick JC, Hayes MR, Grill HJ. Glucagon-like Peptide-1 receptor signaling in the lateral parabrachial nucleus contributes to the control of food intake and motivation to feed. Neuropsychopharmacology. 2014 Aug;39(9):2233-43. doi: 10.1038/npp.2014.74. Epub 2014 Mar 26.'}, {'pmid': '26132939', 'type': 'RESULT', 'citation': 'Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892.'}, {'pmid': '26007339', 'type': 'RESULT', 'citation': 'Pedroso JA, Zampieri TT, Donato J Jr. Reviewing the Effects of L-Leucine Supplementation in the Regulation of Food Intake, Energy Balance, and Glucose Homeostasis. Nutrients. 2015 May 22;7(5):3914-37. doi: 10.3390/nu7053914.'}, {'pmid': '17360978', 'type': 'RESULT', 'citation': 'Zhang Y, Guo K, LeBlanc RE, Loh D, Schwartz GJ, Yu YH. Increasing dietary leucine intake reduces diet-induced obesity and improves glucose and cholesterol metabolism in mice via multimechanisms. Diabetes. 2007 Jun;56(6):1647-54. doi: 10.2337/db07-0123. Epub 2007 Mar 14.'}, {'pmid': '22535285', 'type': 'RESULT', 'citation': 'McAllan L, Cotter PD, Roche HM, Korpela R, Nilaweera KN. Impact of leucine on energy balance. J Physiol Biochem. 2013 Mar;69(1):155-63. doi: 10.1007/s13105-012-0170-2. Epub 2012 Apr 26.'}, {'pmid': '35871930', 'type': 'DERIVED', 'citation': 'Stier C, Koschker AC, Kim M, Stier R, Chiappetta S, Stein J. Fast-track rescue weight reduction therapy to achieve rapid technical operability for emergency bariatric surgery in patients with life-threatening inoperable severe obesity - A proof of concept study. Clin Nutr ESPEN. 2022 Aug;50:238-246. doi: 10.1016/j.clnesp.2022.05.009. Epub 2022 May 26.'}]}, 'descriptionModule': {'briefSummary': 'The frequency of super-super obese who need immediate weight loss surgery is risen continuously. For those patients a prior-to-surgery conditioning therapy is mandatory to gain technical and physical operability. The exclusively well-established preliminary therapy so far was the intragastric balloon, which takes 7 months of treatment time. Due to life-threatening conditions of giant obese patients, who have been admitted to hospital, the investigators were forced to develop a more prompt acting conditioning therapy to bring those individuals in a short run to an improved and "fit-for-surgery" state. In such an impasse the investigators combine Liraglutide with its well-known weight-loss effect with a leucine-based amino acid infusion that is generally used for patients with liver insufficiency, in expectance of an additional weight loss and liver reduction effect.', 'detailedDescription': 'The investigators will use a commercial available amino acid infusion (Aminosteril hepa 8%, Fresenius Karbi), which is used in clinical application for liver conditioning. It is mainly based on the branched-chained amino acid leucine (13.09 g per 1000 ml). The investigators will combine this with a daily subcutaneous injection of Liraglutide. Liraglutide is a GLP-1 analogue, which achieved meanwhile the FDA approval for weight loss treatment. Initial Liraglutide dosage is 1.2 mg for three days, boosted to 1.8 mg consecutively. Participants receive energy reduced nutrition with 1000 kcal/d.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* multimorbid, super-super obese patients\n\nExclusion Criteria:\n\n* renal insufficiency III'}, 'identificationModule': {'nctId': 'NCT02616003', 'briefTitle': 'Preoperative Condition in Giant Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sana Klinikum Offenbach'}, 'officialTitle': 'A Novel Preoperative Conditioning Therapy in Giant Obese Patients With the Combination of Liraglutide and a Leucine-Based Amino-Acid Infusion and Caloric Restriction', 'orgStudyIdInfo': {'id': 'FF 121/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Super-super Obese Patients', 'description': 'Multimorbid, super-super obese patients that need preoperative conditioning therapy (intervention 1: Liraglutide, intervention 2: aminosteril hepa 8%, intervention 3: Caloric diet with 1000 kcal) for weight loss surgery to achieve technical operability.', 'interventionNames': ['Drug: Liraglutide', 'Other: Aminosteril hepa 8%', 'Dietary Supplement: Caloric diet with 1000 kcal']}], 'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['Victoza'], 'description': 'Initially 1.2 mg Liraglutide as subcutaneous daily injection, boosted to 1.8 mg Liraglutide after 3 days subsequently. 1000 ml infusion of aminosteril hepa 8% from day 1 onwards. Caloric diet with 800 kcal from day 1 onwards till technical operability is achieved (about 21 days)', 'armGroupLabels': ['Super-super Obese Patients']}, {'name': 'Aminosteril hepa 8%', 'type': 'OTHER', 'description': 'Initially 1.2 mg Liraglutide as subcutaneous daily injection, boosted to 1.8 mg Liraglutide after 3 days subsequently. 1000 ml infusion of aminosteril hepa 8% from day 1 onwards. Caloric diet with 800 kcal from day 1 onwards till technical operability is achieved (about 21 days)', 'armGroupLabels': ['Super-super Obese Patients']}, {'name': 'Caloric diet with 1000 kcal', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Initially 1.2 mg Liraglutide as subcutaneous daily injection, boosted to 1.8 mg Liraglutide after 3 days subsequently. 1000 ml infusion of aminosteril hepa 8% from day 1 onwards. Caloric diet with 1000 kcal from day 1 onwards till technical operability is achieved (about 21 days)', 'armGroupLabels': ['Super-super Obese Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63069', 'city': 'Offenbach', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Sana Klinikum Offenbach', 'geoPoint': {'lat': 50.10061, 'lon': 8.76647}}], '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'}}}}