Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-30 @ 6:04 AM
Study NCT ID:
NCT01489657
Status:
WITHDRAWN
Last Update Posted:
2016-06-08
First Post:
2011-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Metabolite Profiling of Obese Subjects Before and After Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The results were not significant, therfore the study ended prematurily', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-07', 'studyFirstSubmitDate': '2011-12-08', 'studyFirstSubmitQcDate': '2011-12-08', 'lastUpdatePostDateStruct': {'date': '2016-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Bariatric Surgery', 'Sleeve Gastrectomy', 'Metabolite Profiling'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective observational study is to generate further insight into the numerous metabolic adaptations associated with sleeve gastrectomy surgery in obese subjects by profiled serum metabolites before and after the surgery and integrated metabolite changes with clinical data.', 'detailedDescription': 'In the present study we examine the metabolic fluctuations of the most important amino acids and fatty acids to better understand the metabolic process in weight reduction in obese subjects that underwent sleeve gastrectomy surgery.\n\nThe availability of the tandem equipment for amino acids and fatty acids determinations for the medical system gives us an opportunity to investigate the metabolic turmoil of weight reduction seen in obese subjects after sleeve gastrectomy.\n\nWe evaluated the lipid metabolism by the measurements of the fraction of carnitine fatty acids which is the most available one because only a small blood specimen from a finger puncture is needed.\n\nIn the present study we measured the blood concentrations of monocarboxylic and dicarboxylic fatty acids bounded to carnitine, free carnitine and also free amino acids 2 weeks before the surgery while subjects eat their regular high caloric diet, one week, one month and 3 month after the procedure.\n\nCarnitne fatty acids comprise only the tip of the iceberg of all circulating fatty acids in the blood with a roughly distribution of: triglycerides, phospholipids and cholesteryl fatty acids 4 (Lipids43-65), free fatty acids 0.6, and carnitne fatty acids 0.005 mM. Some additional amount is also circulating in lipoproteins. Even carnitine monocarboxylic fatty acids comprise around 1% of the free fatty acids and around 0.1% of all fatty compounds, the fluctuations in their concentrations probably reflect the most dynamics metabolic events because fatty acid oxidation must initiate by binding fatty acid to carnitine. The concentration of dicarboxylic carnitine fatty acids is much higher and comprises about 2% for malic carnitine and about 10% for glutaric carnitine in the total amount of free acids (http://www.hmdb.ca/). Yet, as for monocarboxylic fatty acids, a remarkable mass of dicarboxylic acids is still present as free acids.\n\nFor all carnitne acyl compounds the distribution forms have a high variability on different physiological conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Bariatric Surgery Clinics', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 30\n* Willing to undergo sleeve gastrectomy\n\nExclusion Criteria:\n\n* Inability to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT01489657', 'briefTitle': 'The Metabolite Profiling of Obese Subjects Before and After Sleeve Gastrectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'The Impact of Sleeve Gastrectomy Surgery in Obese Subjects on Metabolite Profiling', 'orgStudyIdInfo': {'id': 'METPAR1'}}, 'contactsLocationsModule': {'locations': [{'zip': '58100', 'city': 'Holon', 'country': 'Israel', 'facility': 'Wolfson Medical Center, Bariatric Surgery Clinic', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'overallOfficials': [{'name': 'Zohar Landau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wolfson Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Pediatric Endocrinology Service', 'investigatorFullName': 'zohar landau', 'investigatorAffiliation': 'Wolfson Medical Center'}}}}