Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-02-21 @ 12:14 AM
Study NCT ID:
NCT02414893
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2015-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hunger/Satiety's Physiopathologic Study in Morbidly 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-10', 'studyFirstSubmitDate': '2015-03-25', 'studyFirstSubmitQcDate': '2015-04-10', 'lastUpdatePostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hunger and satiety assessment by Visual Analogic Scale', 'timeFrame': '4 hours'}], 'secondaryOutcomes': [{'measure': 'Gastric emptying differences between groups measured by paracetamol absorption test', 'timeFrame': '4 hours'}, {'measure': 'Gallbladder volume differences between groups measured by ultrasonography', 'timeFrame': '4 hours'}, {'measure': 'Ghrelin level differences between groups', 'timeFrame': '4 hours'}, {'measure': 'CCK level differences between groups', 'timeFrame': '4 hours'}, {'measure': 'GLP-1 level differences between groups', 'timeFrame': '4 hours'}, {'measure': 'Glucose homeostasis differences between groups', 'timeFrame': '4 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '26201818', 'type': 'DERIVED', 'citation': 'Mans E, Serra-Prat M, Palomera E, Sunol X, Clave P. Sleeve gastrectomy effects on hunger, satiation, and gastrointestinal hormone and motility responses after a liquid meal test. Am J Clin Nutr. 2015 Sep;102(3):540-7. doi: 10.3945/ajcn.114.104307. Epub 2015 Jul 22.'}]}, 'descriptionModule': {'briefSummary': 'The mechanisms that regulate appetite in the morbidly obese are multifactorial and not well-known. Different peripheral signals (such as ghrelin or cholecystokinin) play an important role in the central regulation of appetite and hunger. Postprandial ghrelin and cholecystokinin (CCK) response has also an effect on gastric emptying that, in turn, has an effect on satiety sensation.\n\nOn the other hand, bariatric surgery is supposed to affect hunger and satiety in and also promotes changes in gastric emptying which are not clearly defined.\n\nAim: To better understand the physiologic mechanisms involved in the regulation of hunger and satiety in morbidly obese individuals, especially those related with gallbladder and gastric emptying, as well as those related with the response of the gastrointestinal hormones ghrelin, CCK and glucagon-like peptide-1 (GLP-1), before and after bariatric surgery (sleeve gastrectomy). Methodology: Three groups of individuals will be studied and compared: group A) non obese healthy subjects, group B) morbidly obese subjects and group C) morbidly obese subjects who had had a previous sleeve gastrectomy. In all subjects a standard meal test after a fasting night will be administered and appetite, satiety and hormonal response (ghrelin, CCK, GLP-1 and insulin) during 4 hours post-ingestion assessed, as well as postprandial gallbladder and gastric emptying by means of ultrasonography and the paracetamol absorption technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Group A: non obese healthy individuals Group B: morbidly obese individuals Group C: individuals who had had a previous sleeve gastrectomy as a bariatric procedures', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup A: non obese individuals (Body Mass Index; BMI \\< 30 Kg/m2) Group B: Fulfilling the National Health Institute (NHI) criteria for bariatric surgery (BMI higher than 40 Kg/m2 or 35 Kg/m2 when related comorbidities) Group C: Previous morbidly obese individuals who had had a sleeve gastrectomy at least 6 months ago.\n\nExclusion Criteria:\n\nGroup A: previous gastric surgery or gallbladder removal. Group B: previous gastric surgery or gallbladder removal. Group C: previous gallbladder removal.'}, 'identificationModule': {'nctId': 'NCT02414893', 'briefTitle': "Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients", 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari del Maresme'}, 'officialTitle': "Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients: Relation Between Hunger/Satiety, Gastric Emptying, Gallbladder Motility and Peripheral Neurohormonal Signs", 'orgStudyIdInfo': {'id': '15/08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non obese'}, {'label': 'Morbidly obese'}, {'label': 'Sleeve gastrectomy', 'interventionNames': ['Procedure: Sleeve gastrectomy']}], 'interventions': [{'name': 'Sleeve gastrectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic vertical gastrectomy as a bariatric procedure.', 'armGroupLabels': ['Sleeve gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08304', 'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Sanitari del Maresme', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorci Sanitari del Maresme', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}