Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-02-20 @ 11:20 AM
Study NCT ID:
NCT02206256
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2014-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function
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': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D031204', 'term': 'Caloric Restriction'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002149', 'term': 'Energy Intake'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-28', 'studyFirstSubmitDate': '2014-07-29', 'studyFirstSubmitQcDate': '2014-07-31', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver volume', 'timeFrame': 'baseline, after treatment', 'description': 'liver volume of the left hepatic lobe measured by MRI'}], 'secondaryOutcomes': [{'measure': 'Peri-operative ex vivo LPS stimulated cytokine production capacity', 'timeFrame': 'baseline, operation day, postoperative day 1, follow up 6 months', 'description': 'IL-6, IL-10, TNF-alpha'}, {'measure': 'Macrophage infiltration in omentum fat biopsies', 'timeFrame': 'Biopsies during gastric bypass surgery'}, {'measure': 'Erythrocyte function', 'timeFrame': 'baseline, day of surgery, postoperative day 1, follow up 6 months', 'description': 'Measurement of erythrocyte deformability and aggregation with LORRCA (laser-assisted optical rotational red cell analyzer)'}, {'measure': 'Cortisol response', 'timeFrame': 'baseline, operation day, postoperative day 1, follow up 6 months', 'description': 'ACTH stimulation test'}, {'measure': 'Serum parameters of inflammatory response', 'timeFrame': 'baseline, operation day, postoperative day 1, follow up 6 months', 'description': 'IL-6, IL-10, TNF-alpha and C-reactive protein'}, {'measure': 'Assessment of the approach of the gastro-oesophageal junction', 'timeFrame': 'During gastric bypass surgery', 'description': 'Surgeons fill out a questionnaire after the gastric bypass surgery'}, {'measure': 'Patient satisfaction with intervention', 'timeFrame': 'After the pre-operative treatment', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '30888593', 'type': 'DERIVED', 'citation': 'Bakker N, van den Helder RS, Geenen RWF, Hunfeld MA, Cense HA, Demirkiran A, Houdijk APJ. Four Weeks of Preoperative Omega-3 Fatty Acids Reduce Liver Volume: a Randomised Controlled Trial. Obes Surg. 2019 Jul;29(7):2037-2044. doi: 10.1007/s11695-019-03814-7.'}]}, 'descriptionModule': {'briefSummary': 'Gastric bypass surgery is the gold standard in bariatric surgery and is a successful method to reduce weight in morbidly obese subjects. Patients qualified for gastric bypass surgery are routinely pre-treated with a low calorie diet in order to reduce liver volume and to facilitate the approach of the gastro-oesophageal junction. Pre-treatment with omega-3 fatty acids has similar effects on liver volume, but a prospective comparison of both treatments has not been performed yet. Morbidly obese patients respond differently to surgical stress, due to a number of factors. First, obesity is associated with a low-grade inflammatory state induced by an increased amount of macrophages in adipose tissue. This state is associated with higher levels of pro-inflammatory cytokines in serum and with a less adequate immune response to infections. Second, obesity is associated with an altered cortisol metabolism possibly related to adrenal insufficiency. This could play an important role in the altered response to surgical stress and postoperative complications in obese subjects. Third, obesity is associated with altered erythrocyte function, including decreased erythrocyte deformability and increased aggregation, factors contributing to an impaired microcirculation.\n\nThis study has a number of different aims. First, we will compare pre-treatment with the standard low calorie diet with omega-3 fatty acids on liver volume in patients qualified for gastric bypass surgery because of morbid obesity. Second, we will investigate the effect of omega-3 fatty acids on immune function, the low-inflammatory state of adipose tissue, the stress response of obese subjects before and erythrocyte function. Third, we will investigate the effect of gastric bypass surgery by comparing values before surgery with values on the first postoperative day and 6 months after surgery regarding to immunological parameters, stress response and erythrocyte function.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females undergoing laparoscopic gastric bypass surgery because of morbid obesity\n* Age between 18 and 65 years\n* Able to fit in the MRI\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Diabetes mellitus type 1\n* Current history of inflammatory, infectious or malignant disease\n* Daily use of anti-inflammatory drugs\n* Contra-indications for MRI imaging\n* Contra-indications for the use of omega-3 fatty acids'}, 'identificationModule': {'nctId': 'NCT02206256', 'acronym': 'OLIVIER', 'briefTitle': 'Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function', 'organization': {'class': 'OTHER', 'fullName': 'Medical Center Alkmaar'}, 'officialTitle': 'Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function', 'orgStudyIdInfo': {'id': 'NL47021.029.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low calorie diet', 'description': 'Low calorie diet 2 weeks pre-operatively', 'interventionNames': ['Behavioral: Low calorie diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omega-3 fatty acid capsules', 'description': '2 times a day 1 capsule for 4 weeks before gastric bypass surgery', 'interventionNames': ['Drug: Omega-3 fatty acid capsules']}], 'interventions': [{'name': 'Omega-3 fatty acid capsules', 'type': 'DRUG', 'otherNames': ['purified fish oil', 'omega-3 fatty acids', 'eicosapentoenoic acid (EPA)', 'docosahexaenoic acid (DHA)'], 'description': '2 times a day 1 capsule for 4 weeks before gastric bypass surgery', 'armGroupLabels': ['Omega-3 fatty acid capsules']}, {'name': 'Low calorie diet', 'type': 'BEHAVIORAL', 'description': 'A low calorie diet of 600 kcal/day during 2 weeks, using Modifast or an adjusted normal diet.', 'armGroupLabels': ['Low calorie diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1942 LE', 'city': 'Beverwijk', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Rode Kruis Ziekenhuis', 'geoPoint': {'lat': 52.48333, 'lon': 4.65694}}], 'overallOfficials': [{'name': 'A.P.J. Houdijk, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rode Kruis Ziekenhuis, Medisch Centrum Alkmaar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Center Alkmaar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Alexander P.J. Houdijk', 'investigatorAffiliation': 'Medical Center Alkmaar'}}}}