Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-05 @ 6:35 PM
Study NCT ID:
NCT03330756
Status:
UNKNOWN
Last Update Posted:
2017-11-09
First Post:
2017-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of the Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Mini Gastric Bypass on the Remission of Type II Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, open randomized controlled clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-08', 'studyFirstSubmitDate': '2017-10-13', 'studyFirstSubmitQcDate': '2017-10-30', 'lastUpdatePostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glycaemic control', 'timeFrame': '12 months FU', 'description': 'as measured by the difference in HBa1C'}], 'secondaryOutcomes': [{'measure': 'glycaemic control', 'timeFrame': '6 and 24 months FU', 'description': 'as measured by the difference in HBa1C'}, {'measure': 'glycaemic control', 'timeFrame': '6, 12 and 24 months FU', 'description': 'as measured by the difference in HBa1C and anti-diabetic medication'}, {'measure': 'Insulin sensitivity', 'timeFrame': 'baseline, 12, 24 months FU', 'description': 'Mixed meal tolerance test for level of insulin sensitivity'}, {'measure': 'NAFLD/NASH', 'timeFrame': 'day of surgery, reoperation', 'description': 'NAFLD/NASH parameters in liver biopsy measured with the Steatosis, Activity and Fibrosis (SAF) score according to Bedossa et al (2012).For each patient a SAF score summarizing the main histological lesions will be defined. The steatosis score (S) will assess the quantities of larger or median-sized lipid droplets but not foamy microvesicules from 0 to 3 (S0 \\<5%; S1 5-33%; S2 34-66% and S3\\>67%). Activity grade (A) from 0-4 is the unweighted addition of hepatocyte ballooning (0-2) and lobular inflammation (0-2). Stage of fibrosis will be assessed using the score described by NASH-CRN as follows; stage 0 (F0) no fibrosis; stage 1 (F1) 1a or 1b perisinusoidal zone 3 or 1c portal fibrosis; stage 2 (F2) persinusoidal and periportal fibrosis without bridging; stage 3 (F3) bridging fibrosis and stage 4 (F4) cirrhosis. A diagnostic algorithm which will be used during this study can be found in the original paper published by Bedossa et al.'}, {'measure': 'Presence of bacterial DNA/bacterial metabolites - portal vein', 'timeFrame': 'day of surgery, reoperation', 'description': 'in portal vein blood'}, {'measure': 'Presence of bacterial DNA/bacterial metabolites - liver', 'timeFrame': 'day of surgery, reoperation', 'description': 'in liver'}, {'measure': 'Presence of bacterial DNA/bacterial metabolites - abdominal adipose tissue', 'timeFrame': 'day of surgery, reoperation', 'description': 'in abdominal adipose tissue depots'}, {'measure': 'Expression and differentiation of intestinal immunological cells - GALT', 'timeFrame': 'day of surgery, reoperation', 'description': 'in GALT'}, {'measure': 'Expression and differentiation of intestinal immunological cells - abdominal adipose tissue', 'timeFrame': 'day of surgery, reoperation', 'description': 'in abdominal adipose tissue depots'}, {'measure': 'Expression and differentiation of intestinal immunological cells - liver', 'timeFrame': 'day of surgery, reoperation', 'description': 'in liver'}, {'measure': 'Expression and differentiation of intestinal immunological cells - peripheral blood', 'timeFrame': 'day of surgery, reoperation', 'description': 'in peripheral blood'}, {'measure': 'Expression and differentiation of immunological cells', 'timeFrame': '12 and 24 months FU', 'description': "ILC's, macrophages"}, {'measure': 'Expression and differentiation of inflammatory markers', 'timeFrame': '12 and 24 months FU', 'description': 'IL6, IRX3 and 5'}, {'measure': 'Small intestinal and fecal microbiota composition', 'timeFrame': '2, and 6 weeks, 6 months, as well as 12 and 24 months after surgery', 'description': 'feces'}, {'measure': 'Peripheral blood inflammatory markers', 'timeFrame': '2, and 6 weeks, 6 months, as well as 12 and 24 months after surgery', 'description': "ILC's, macrophages, T/B-cells and dendritic cells"}, {'measure': 'Eating habits', 'timeFrame': 'baseline, 12, 24 months FU', 'description': 'G-food craving questionnaire (FCQ-T) 21 item questionaire scale 0 (never) - 6 (always)'}, {'measure': 'Eating habits', 'timeFrame': 'baseline, 12, 24 months FU', 'description': '10 questions, scale 0-10 for instance 0 not hungry -10 very hungry / satiety / craving salty food / craving sweet food / craving fat food'}, {'measure': 'Excreted metabolites', 'timeFrame': 'baseline, 12, 24 months FU', 'description': 'urine'}, {'measure': 'Bio electric impedance', 'timeFrame': 'baseline, 12, 24 months FU', 'description': 'body composition as assesed by bioelectical impedance analysis (BIA): the measurement of body fat in relation to lean body mass.'}, {'measure': 'Quality of life', 'timeFrame': 'baseline, 12, 24 months FU', 'description': 'Quality of life (IWQOL lite) 5 domain questionaire, 31 items: 1 never true - 5 always true'}, {'measure': 'Cardiac / ventricular hypertrophy', 'timeFrame': 'baseline, 12, 24 months FU', 'description': 'Electrocardiogram (ECG)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Roux-en-Y gastric bypass', 'Mini gastric bypass', 'Type 2 diabetes mellitus', 'Morbid Obesity'], 'conditions': ['Obesity, Morbid', 'Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '37626349', 'type': 'DERIVED', 'citation': 'Pyykko JE, Hinnen C, Aydin O, Nieuwdorp M, De Brauw LM, Bruin SC, van Olst N, Gerdes VEA, Sanderman R, Hagedoorn M. Attachment style and post-bariatric surgery health behaviours: the mediating role of self-esteem and health self-efficacy. BMC Psychol. 2023 Aug 25;11(1):248. doi: 10.1186/s40359-023-01273-5.'}, {'pmid': '36273149', 'type': 'DERIVED', 'citation': 'van Rijswijk A, van Olst N, Meijnikman AS, Acherman YIZ, Bruin SC, van de Laar AW, van Olden CC, Aydin O, Borger H, Beuers UHW, Herrema H, Verheij J, Apers JA, Backhed F, Gerdes VEA, Nieuwdorp M, de Brauw LM. The effects of laparoscopic Roux-en-Y gastric bypass and one-anastomosis gastric bypass on glycemic control and remission of type 2 diabetes mellitus: study protocol for a multi-center randomized controlled trial (the DIABAR-trial). Trials. 2022 Oct 22;23(1):900. doi: 10.1186/s13063-022-06762-3.'}]}, 'descriptionModule': {'briefSummary': "It is estimated that there will be 439-552 million people with type 2 diabetes mellitus (T2DM) globally in 2030. Type 2 Diabetes Mellitus is present in one quarter of patients at the bariatric outpatient clinic. It is undecided which metabolic surgery grants best results in the remission of T2DM and which procedure does that at the lowest rate of surgical complications, long term difficulties and side effects. Non alcoholic fatty liver disease (NAFLD) is present in 80% of all morbidly obese subjects and is a major risk factor for development of insulin resistance and non alcoholic steatohepatis (NASH). It is increasingly recognized that the immune system, possibly driven by innate lymphoid cells (ILC's), and the intestinal microbiome are major players in this obesity related disease and the switch from benign to malign (insulin resistance and T2DM) obesity. However, the exact mechanisms of action behind the surgery-driven switch back from malign to benign obesity are unknown.Primary objective is to evaluate and compare the glycaemic control in T2DM within the first year of LRYGB and LMBG. Secondary aim is to gain insight in the pathophysiological mechanisms that drive the conversion of malign to benign obesity.", 'detailedDescription': "Metabolic surgery has proven to be a viable long-term solution in the treatment of morbid obesity and its comorbidities. It induces rapid remission of type 2 diabetes mellitus (T2DM). Type 2 Diabetes Mellitus is present in one quarter of patients at the bariatric outpatient clinic. Non alcoholic fatty liver disease (NAFLD) is present in 80% of all morbidly obese subjects and is a major risk factor for development of insulin resistance and non alcoholic steatohepatis (NASH), with the latter becoming the major indication for liver transplantation in the USA. It is increasingly recognized that the immune system, possibly driven by innate lymphoid cells (ILC's), and the intestinal microbiome are major players in this obesity related disease and the switch from benign to malign (insulin resistance and T2DM) obesity. However, the exact mechanisms of action behind the surgery-driven switch back from malign to benign obesity are unknown. Also, it is undecided which metabolic surgery grants best results in the remission of T2DM and which procedure does that at the lowest rate of surgical complications, long term difficulties and side effects. The Laparoscopic Roux-en-Y Gastric Bypass (LRYGB), an efficient but complex procedure, is the golden standard in the Netherlands. The Laparoscopic Mini Gastric Bypass (LMGB) is technically less challenging and has been introduced to overcome some of the limitations of LRYGB. It has been hypothesized that the LMGB has a more rapid and durable glycaemic control, possibly due to the altered constitution and the augmented length of the biliary limb. There is reason to believe that the improved glycaemic control might become apparent within the first year of surgery and that it might remain thereafter. However, it is unknown what order of magnitude is to be expected and whether subgroups of T2DM patients will benefit the LMGB more. Also, it is unknown whether and to what extent intestinal microbiota and immunological tone can predict the metabolic response (improvement in insulin sensitivity) and NAFLD/NASH reduction and whether differences are expected between these two surgeries. Increased understanding of the pathophysiological mechanisms as well as their relationship to metabolic disturbances are thought to be of crucial importance to discover new diagnostic and therapeutical targets in obesity associated insulin resistance/T2DM and NAFLD/NASH. Primary objective is to evaluate and compare the glycaemic control in T2DM within the first year of LRYGB and LMBG. Secondary aim is to gain insight in the pathophysiological mechanisms that drive the conversion of malign to benign obesity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥35 and ≤50 kg/m2\n* Diagnosis and treatment of T2DM at intake at bariatric ward with use of anti-diabetic medication.\n* American Society of Anaesthesiologist Classification (ASA) ≤3\n* All patients are required to lose 6 kilograms of weight prior to surgery\n\nExclusion Criteria:\n\n* Known genetic basis for insulin resistance or glucose intolerance\n* Type 1 DM\n* Prior Bariatric surgery\n* Patients requiring a concomitant intervention (such as cholecystectomy, ventral hernia repair)\n* Auto-immune gastritis\n* Known presence of gastro-esophageal reflux disease\n* Known presence of large hiatal hernia requiring concomitant surgical repair\n* Coagulation disorders (PT time \\> 14 seconds, aPTT ((dependent on laboratory methods) or known presence of bleeding disorders (anamnestic))\n* Known presence of hemoglobinopathy\n* Uncontrolled hypertension (RR \\> 150/95 mmHg)\n* Renal insufficiency (creatinine \\> 150 umol/L)\n* Pregnancy\n* Breastfeeding\n* Alcohol or drug dependency\n* Primary lipid disorder\n* Participation in any other (therapeutic) study that may influence primary or secondary outcomes'}, 'identificationModule': {'nctId': 'NCT03330756', 'acronym': 'DIABAR', 'briefTitle': 'The Effects of the Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Mini Gastric Bypass on the Remission of Type II Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Slotervaart Hospital'}, 'officialTitle': 'The Effects of the Laparoscopic Roux-en-Y Gastric Bypass and the Laparoscopic Mini Gastric Bypass on the Remission of Type II Diabetes Mellitus and the Pathophysiological Mechanisms That Drive the Conversion of Malign to Benign Obesity', 'orgStudyIdInfo': {'id': 'P1729'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic Roux-en-Y gastric bypass', 'description': 'Laparoscopic Roux-en-Y gastric bypass', 'interventionNames': ['Procedure: laparoscopic Roux-en-Y gastric bypass']}, {'type': 'EXPERIMENTAL', 'label': 'Laparoscopic Mini Gastric Bypass', 'description': 'laparoscopic Mini gastric bypass', 'interventionNames': ['Procedure: laparoscopic Mini gastric bypass']}], 'interventions': [{'name': 'laparoscopic Roux-en-Y gastric bypass', 'type': 'PROCEDURE', 'otherNames': ['gastric bypass'], 'description': 'laparoscopic Roux-en-Y gastric bypass with a 50 cm biliary limb and a 150 cm alimentary limb', 'armGroupLabels': ['Laparoscopic Roux-en-Y gastric bypass']}, {'name': 'laparoscopic Mini gastric bypass', 'type': 'PROCEDURE', 'otherNames': ['One anastomosis gastric bypass, omega loop gastric bypass'], 'description': 'laparoscopic Mini gastric bypass with a gastrojejunostomy at 200 centimeters measured from the ligament of Treitz', 'armGroupLabels': ['Laparoscopic Mini Gastric Bypass']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066EC', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Anne-Sophie van Rijswijk, MD', 'role': 'CONTACT', 'email': 'anne-sophie.vanrijswijk@slz.nl', 'phone': '+31205014460'}, {'name': 'Maurtis de Brauw, MD PhD', 'role': 'CONTACT', 'email': 'maurits.debrauw@slz.nl'}], 'facility': 'medical Center Slotervaart', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Anne-Sophie van Rijswijk, MD', 'role': 'CONTACT', 'email': 'anne-sophie.vanrijswijk@slz.nl', 'phone': '+31205124460'}, {'name': 'Maurits de Brauw, MD PhD', 'role': 'CONTACT', 'email': 'maurits.debrauw@slz.nl'}], 'overallOfficials': [{'name': 'Maurits de Brauw, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of department of Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Slotervaart Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}