Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT01652105
Status:
UNKNOWN
Last Update Posted:
2012-08-07
First Post:
2012-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Trial of Preoperative Diets Before Bariatric Surgery
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-06', 'studyFirstSubmitDate': '2012-07-25', 'studyFirstSubmitQcDate': '2012-07-25', 'lastUpdatePostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative weight loss before bariatric surgery', 'timeFrame': '2 weeks', 'description': 'Weight loss in kg before operation'}], 'secondaryOutcomes': [{'measure': '- operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients', 'timeFrame': '2 weeks', 'description': 'Measured by VAS, diet books and questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastric bypass', 'Preoperative diet', 'Prodimed'], 'conditions': ['Morbid Obesity', 'Bariatric Surgery', 'Gastric Bypass']}, 'descriptionModule': {'briefSummary': 'Randomized clinical trial of two preoperative diets before bariatric surgery (gastric bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected for a gastric bypass procedure', 'detailedDescription': "Morbid obesity, defined as a body mass index (BMI) of \\> 40 kg/m² or \\> 35 kg/m² with obesity-related comorbidities, is a rapidly growing problem in the western society. In the United States, about 6 million people currently have a BMI of \\> 40 kg/m² and another 10 million people have a BMI of \\> 35 kg/m² with comorbidities. Worldwide, the incidence of morbid obesity has doubled and about 300 million people are now obese. In the Netherlands the prevalence is less disturbing but the incidence of morbid obesity is rising progressively to 1.5% of the total population. At this moment surgical therapy is the only treatment option for these patients that results in sufficient long-term weight loss. Non-surgical approaches, like low energy diets and behavior modification, are not successful in the long-term with respect to maintaining weight loss and decreasing obesity-related comorbidities.\n\nIn order to increase weight loss and minimize complications a preoperative diet before bariatric has been advocated. However, the usual VLCD's are poorly tolerated by patients. In this study we aim to compare two preoperative diets in order to find the most suitable for this patient population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* morbid obesity according to IFSO criteria\n\nExclusion Criteria:\n\n* previous bariatric or gastric surgery\n* severe psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT01652105', 'briefTitle': 'Randomized Trial of Preoperative Diets Before Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Lievensberg Ziekenhuis'}, 'officialTitle': 'Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'rubenschouten1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diet', 'description': 'New developed diet', 'interventionNames': ['Dietary Supplement: Standard diet versus standard VLCD (Prodimed)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prodimed', 'description': 'Standard VLCD', 'interventionNames': ['Dietary Supplement: Standard diet versus standard VLCD (Prodimed)']}], 'interventions': [{'name': 'Standard diet versus standard VLCD (Prodimed)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Diet', 'Prodimed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4624 VT', 'city': 'Bergen op Zoom', 'country': 'Netherlands', 'contacts': [{'name': 'Ruben Schouten, Md, PhD', 'role': 'CONTACT', 'email': 'schoutenruben@hotmail.com'}], 'facility': 'Bariatric Centre Lievensberg hospital', 'geoPoint': {'lat': 51.495, 'lon': 4.29167}}], 'centralContacts': [{'name': 'Ruben Schouten, Md, PhD', 'role': 'CONTACT', 'email': 'schoutenruben@hotmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lievensberg Ziekenhuis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'R. Schouten', 'investigatorAffiliation': 'Lievensberg Ziekenhuis'}}}}