Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-02-28 @ 7:10 PM
Study NCT ID:
NCT06374368
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2021-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Small Bowel Diversion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total body weight loss', 'timeFrame': '36 months', 'description': 'Weight change in percentage'}, {'measure': 'Glycated hemoglobin loss', 'timeFrame': '36 months', 'description': 'Glycated hemoglobin change in blood'}, {'measure': 'Diabetes medication loss', 'timeFrame': '36 months', 'description': 'Reduction in diabetes medication requirements (for diabetic cohort) - absolute value'}, {'measure': 'Total cholesterol loss', 'timeFrame': '36 months', 'description': 'Total cholesterol loss in blood'}, {'measure': 'Low density lipoprotein loss', 'timeFrame': '36 months', 'description': 'Low density lipoprotein loss in blood'}, {'measure': 'High density lipoprotein loss', 'timeFrame': '36 months', 'description': 'High density lipoprotein loss in blood'}, {'measure': 'Leptin metabolism evaluation', 'timeFrame': '36 months', 'description': 'Leptin value increase/decrease in blood'}, {'measure': 'Adiponectin metabolism evaluation', 'timeFrame': '36 months', 'description': 'Adiponectin value increase/decrease in blood'}, {'measure': 'Bile acids metabolism evaluation', 'timeFrame': '36 months', 'description': 'Bile acids value increase/decrease in blood'}], 'secondaryOutcomes': [{'measure': 'Change from baseline quality of life-Lite', 'timeFrame': '36 months', 'description': 'Questionary "Weight on Quality of Life-Lite (IWQOL-Lite)"'}, {'measure': 'Change from baseline quality of life - Sort Form Survey', 'timeFrame': '36 months', 'description': 'Questionary "36-Item Short Form Survey (SF-36)"'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Type 2 Diabetes', 'Partial Jejunal Diversion', 'Partial Jejuno-colic Diversion', 'Bariatric surgery', 'Metabolic surgery', 'Side-to-Side Anastomosis'], 'conditions': ['Obesity', 'Type2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '22709383', 'type': 'BACKGROUND', 'citation': 'Walpole SC, Prieto-Merino D, Edwards P, Cleland J, Stevens G, Roberts I. The weight of nations: an estimation of adult human biomass. BMC Public Health. 2012 Jun 18;12:439. doi: 10.1186/1471-2458-12-439.'}, {'pmid': '15479938', 'type': 'BACKGROUND', 'citation': 'Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.'}, {'pmid': '24135948', 'type': 'BACKGROUND', 'citation': 'Fried M, Yumuk V, Oppert JM, Scopinaro N, Torres AJ, Weiner R, Yashkov Y, Fruhbeck G; European Association for the Study of Obesity; International Federation for the Surgery of Obesity - European Chapter. Interdisciplinary European Guidelines on metabolic and bariatric surgery. Obes Facts. 2013;6(5):449-68. doi: 10.1159/000355480. Epub 2013 Oct 11.'}, {'pmid': '17715408', 'type': 'BACKGROUND', 'citation': 'Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.'}, {'pmid': '21705069', 'type': 'BACKGROUND', 'citation': 'Danaei G, Finucane MM, Lu Y, Singh GM, Cowan MJ, Paciorek CJ, Lin JK, Farzadfar F, Khang YH, Stevens GA, Rao M, Ali MK, Riley LM, Robinson CA, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Blood Glucose). National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2.7 million participants. Lancet. 2011 Jul 2;378(9785):31-40. doi: 10.1016/S0140-6736(11)60679-X. Epub 2011 Jun 24.'}, {'pmid': '19949889', 'type': 'BACKGROUND', 'citation': 'Hofso D, Jenssen T, Hager H, Roislien J, Hjelmesaeth J. Fasting plasma glucose in the screening for type 2 diabetes in morbidly obese subjects. Obes Surg. 2010 Mar;20(3):302-7. doi: 10.1007/s11695-009-0022-5. Epub 2009 Dec 1.'}, {'pmid': '22670692', 'type': 'BACKGROUND', 'citation': 'Honzikova N, Krticka A, Zavodna E, Javorka M, Tonhajzerova I, Javorka K. Spectral peak frequency in low-frequency band in cross spectra of blood pressure and heart rate fluctuations in young type 1 diabetic patients. Physiol Res. 2012;61(4):347-54. doi: 10.33549/physiolres.932300. Epub 2012 Jun 6.'}, {'pmid': '27957699', 'type': 'BACKGROUND', 'citation': 'Rubino F, Nathan DM, Eckel RH, Schauer PR, Alberti KG, Zimmet PZ, Del Prato S, Ji L, Sadikot SM, Herman WH, Amiel SA, Kaplan LM, Taroncher-Oldenburg G, Cummings DE; Delegates of the 2nd Diabetes Surgery Summit. Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: a Joint Statement by International Diabetes Organizations. Obes Surg. 2017 Jan;27(1):2-21. doi: 10.1007/s11695-016-2457-9.'}, {'pmid': '27222549', 'type': 'BACKGROUND', 'citation': 'Adams TD, Arterburn DE, Nathan DM, Eckel RH. Clinical Outcomes of Metabolic Surgery: Microvascular and Macrovascular Complications. Diabetes Care. 2016 Jun;39(6):912-23. doi: 10.2337/dc16-0157.'}, {'pmid': '22449317', 'type': 'BACKGROUND', 'citation': 'Mingrone G, Panunzi S, De Gaetano A, Guidone C, Iaconelli A, Leccesi L, Nanni G, Pomp A, Castagneto M, Ghirlanda G, Rubino F. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012 Apr 26;366(17):1577-85. doi: 10.1056/NEJMoa1200111. Epub 2012 Mar 26.'}, {'pmid': '12409659', 'type': 'BACKGROUND', 'citation': 'Rubino F, Gagner M. Potential of surgery for curing type 2 diabetes mellitus. Ann Surg. 2002 Nov;236(5):554-9. doi: 10.1097/00000658-200211000-00003.'}, {'pmid': '24352617', 'type': 'BACKGROUND', 'citation': 'Chang SH, Stoll CR, Song J, Varela JE, Eagon CJ, Colditz GA. The effectiveness and risks of bariatric surgery: an updated systematic review and meta-analysis, 2003-2012. JAMA Surg. 2014 Mar;149(3):275-87. doi: 10.1001/jamasurg.2013.3654.'}, {'pmid': '15273546', 'type': 'BACKGROUND', 'citation': 'Rubino F, Gagner M, Gentileschi P, Kini S, Fukuyama S, Feng J, Diamond E. The early effect of the Roux-en-Y gastric bypass on hormones involved in body weight regulation and glucose metabolism. Ann Surg. 2004 Aug;240(2):236-42. doi: 10.1097/01.sla.0000133117.12646.48.'}, {'pmid': '17030966', 'type': 'BACKGROUND', 'citation': 'Korner J, Inabnet W, Conwell IM, Taveras C, Daud A, Olivero-Rivera L, Restuccia NL, Bessler M. Differential effects of gastric bypass and banding on circulating gut hormone and leptin levels. Obesity (Silver Spring). 2006 Sep;14(9):1553-61. doi: 10.1038/oby.2006.179.'}, {'pmid': '17416796', 'type': 'BACKGROUND', 'citation': 'Laferrere B, Heshka S, Wang K, Khan Y, McGinty J, Teixeira J, Hart AB, Olivan B. Incretin levels and effect are markedly enhanced 1 month after Roux-en-Y gastric bypass surgery in obese patients with type 2 diabetes. Diabetes Care. 2007 Jul;30(7):1709-16. doi: 10.2337/dc06-1549. Epub 2007 Apr 6.'}, {'pmid': '20098450', 'type': 'BACKGROUND', 'citation': "Rubino F, R'bibo SL, del Genio F, Mazumdar M, McGraw TE. Metabolic surgery: the role of the gastrointestinal tract in diabetes mellitus. Nat Rev Endocrinol. 2010 Feb;6(2):102-9. doi: 10.1038/nrendo.2009.268."}, {'pmid': '27292926', 'type': 'BACKGROUND', 'citation': 'Ponnusamy V, Owens AP, Purkayastha S, Iodice V, Mathias CJ. Orthostatic intolerance and autonomic dysfunction following bariatric surgery: A retrospective study and review of the literature. Auton Neurosci. 2016 Jul;198:1-7. doi: 10.1016/j.autneu.2016.05.003. Epub 2016 May 31.'}, {'pmid': '22090279', 'type': 'BACKGROUND', 'citation': 'Straznicky NE, Eikelis N, Nestel PJ, Dixon JB, Dawood T, Grima MT, Sari CI, Schlaich MP, Esler MD, Tilbrook AJ, Lambert GW, Lambert EA. Baseline sympathetic nervous system activity predicts dietary weight loss in obese metabolic syndrome subjects. J Clin Endocrinol Metab. 2012 Feb;97(2):605-13. doi: 10.1210/jc.2011-2320. Epub 2011 Nov 16.'}, {'pmid': '27137224', 'type': 'BACKGROUND', 'citation': 'Casellini CM, Parson HK, Hodges K, Edwards JF, Lieb DC, Wohlgemuth SD, Vinik AI. Bariatric Surgery Restores Cardiac and Sudomotor Autonomic C-Fiber Dysfunction towards Normal in Obese Subjects with Type 2 Diabetes. PLoS One. 2016 May 3;11(5):e0154211. doi: 10.1371/journal.pone.0154211. eCollection 2016.'}, {'pmid': '17386391', 'type': 'BACKGROUND', 'citation': 'Cummings DE, Overduin J, Foster-Schubert KE, Carlson MJ. Role of the bypassed proximal intestine in the anti-diabetic effects of bariatric surgery. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):109-15. doi: 10.1016/j.soard.2007.02.003. No abstract available.'}, {'pmid': '18316951', 'type': 'BACKGROUND', 'citation': 'Moo TA, Rubino F. Gastrointestinal surgery as treatment for type 2 diabetes. Curr Opin Endocrinol Diabetes Obes. 2008 Apr;15(2):153-8. doi: 10.1097/MED.0b013e3282f88a0a.'}]}, 'descriptionModule': {'briefSummary': "In an effort to replicate metabolic surgery's durable results in metabolic disease while minimizing its risks, two innovative methods has been created. Two surgical methods to create a bowel-to-bowel anastomosis, similar to the type used in current metabolic surgeries. It be to create a jejuno-ileal, side-to-side anastomosis and jejunocolic side-to-side anastomosis. The side-to-side jejuno-ileal anastomosis and side-to-side jejunocolic anastomosis provides two routes for ingested food. The new, shorter route has a malabsorptive effect similar to that seen in Roux en-Y gastric bypass (RYGB) and biliopancreatic diversion (BPD) - procedures which leads to weight loss. Additionally, delivery of non-absorbed macronutrients to the distal ileum, or transverse colon can enhance incretin effect and improve Type 2 Diabetes Mellitus parameters. However, the native route is also preserved, which theoretically reduces the risk of malnutrition, diarrhea, and metabolic derangements seen in other metabolic surgeries.The side-to-side jejuno-ileal anastomosis was already tested in the Pilot Study of the GI Windows Self-Forming Magnetic (SFM) Anastomosis Device for Creation of an Incisionless Small Bowel Bypass for Treatment of Obesity and Diabetes in year 2015 (15). The results of this study demonstrated the safety of this approach without serious adverse events. This non-surgical approach resulted in significant weight loss, favorable changes in insulin and incretin responses to a mixed meal and significant improvement in HbA1c in T2DM (16).In summary, metabolic diseases are a growing pandemic with suboptimal clinical solutions. The surgical side-to-side jejuno-ileal anastomosis and side-to-side jejuno-colic anastomosis without gastrectomy potentially represents a new class of therapy that may produce durable clinical results generally associated with surgery while minimizing its attendant risks.", 'detailedDescription': 'The study subjects who meet Inclusion criteria and baseline procedures undergo surgery (jejunal-ileal diversion/ jejuno-colic diversion). The surgery is performed in general anesthesia with orotracheal intubation. The laparoscopic approach is used. After establishing pneumoperitoneum (insufluation of the abdominal cavity with CO2) the 1th. trocar and laparoscopic camera are introduced through small incision. After visual control of abdominal cavity additional 2-3 trocars for operating instruments are introduced. The site of future anastomosis is identified (45 cm from ligament of Treitz on jejunum and 45 cm for the ileocoecal junction on ileum). The anastomosis between these two parts of jejunum and ileum is created by the means of linear stapler (45 mm), The residual defect is closed by manual continuous suture. The food will be passed through intestine partially through whole small intestine and partially through the anastomosis. In the second group of patients is the anastomosis created between jejunum (45 from ligament of Treitz) and transverse colon (behind the liver flexure) by means of the same technique. Before the end of the operation the control of bleeding is performed. Afterwards the trocars are removed under visual control. The pneumoperitoneum is released and the incisions are sutured. The subject will have follow-up clinic visits specific to the study at weeks 1, 2, and 3 and at months 1, 2, 3, 6, 12, 18, 24, 30 and 36 after the original procedure. At each clinic visit, the subject will undergo review of medical history, assessment for adverse events, physical examination (including weight and girth measurements) and blood work (e.g. glycated hemoglobin HbA1c). At specific intervals, principal metabolic studies will be performed, including a mixed meal tolerance test. Upper GI series radiographic studies at baseline and 14days after procedure as well as at the discretion of the principal investigator, will be performed, focusing on the patency of the anastomosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-65 years at screening;\n* Body mass index ≥30 or ≤50kg/m2;\n* If subject has Type 2 Diabetes: fasting plasma glucose greater than 6,1 mmol/l at time of enrollment if not treated with anti-diabetic medication;\n* If on no diabetes medications, Hemoglobin A1C between and including 6.5 and 9.0 at time of enrollment.\n\nExclusion Criteria:\n\n* Body Mass Index \\>50 or \\<30 kg/m2;\n* Diagnosis of Type 2 diabetes less than 6 months;\n* History of suspected gastrointestinal disease (for example cirrhosis, inflammatory bowel disease);\n* History of active malignancy (not in remission) with the exception of squamous or basal cell carcinoma of the skin;\n* Ongoing systemic infection;\n* Chronic pancreatitis;\n* Chronic liver disease of any cause;\n* Poorly controlled psychiatric disease (for example ongoing major depression, schizophrenia, borderline personality, suicidality, psychosis);\n* Any history of an eating disorder within the past 5 years;\n* Pre-existing severe comorbid cardio-respiratory disease (for example congestive heart failure, cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease, pulmonary embolism);\n* uncontrolled hypertension (systolic Blood Preassure \\> 150 mm Hg or diastolic Blood Preassure \\> 100 mm Hg).'}, 'identificationModule': {'nctId': 'NCT06374368', 'briefTitle': 'Small Bowel Diversion', 'organization': {'class': 'OTHER', 'fullName': 'University of Ostrava'}, 'officialTitle': 'Jejuno-Ileal and Jejuno-Colic Diversion as a New Bariatric Method in the Treatment of Diabetes and Obesity: Study Protocol for a Prospective Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'JID-SURG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'obese patients with jejuno-ileal diversion', 'description': 'Jejuno-ileal diversion without gastric restriction using standard bariatric surgical technique with standard staplers and surgical suturing.', 'interventionNames': ['Procedure: jejuno-ileal diversion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'obese patients with jejuno-colic diversion', 'description': 'Jejuno-colic diversion without gastric restriction using standard bariatric surgical technique with standard staplers and surgical suturing', 'interventionNames': ['Procedure: jejuno-colic diversion']}], 'interventions': [{'name': 'jejuno-ileal diversion', 'type': 'PROCEDURE', 'description': 'The surgery is performed in general anesthesia with orotracheal intubation. The laparoscopic approach is used. After establishing pneumoperitoneum (insufluation of the abdominal cavity with CO2) the 1th. trocar and laparoscopic camera are introduced through small incision. After visual control of abdominal cavity additional 2-3 trocars for operating instruments are introduced. The site of future anastomosis is identified (45 cm from ligament of Treitz on jejunum and 45 cm for the ileocoecal junction on ileum). The anastomosis between these two parts of jejunum and ileum is created by the means of linear stapler (45 mm).', 'armGroupLabels': ['obese patients with jejuno-ileal diversion']}, {'name': 'jejuno-colic diversion', 'type': 'PROCEDURE', 'description': 'The surgery is performed in general anesthesia with orotracheal intubation. The laparoscopic approach is used. After establishing pneumoperitoneum (insufluation of the abdominal cavity with CO2) the 1th. trocar and laparoscopic camera are introduced through small incision. After visual control of abdominal cavity additional 2-3 trocars for operating instruments are introduced. The anastomosis is created between jejunum (45 from ligament of Treitz) and transverse colon (behind the liver flexure).', 'armGroupLabels': ['obese patients with jejuno-colic diversion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Ostrava', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Marek Bužga', 'role': 'CONTACT', 'email': 'marek.buzga@osu.cz', 'phone': '+420553462823'}, {'name': 'Marek Bužga', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'city': 'Ostrava', 'status': 'COMPLETED', 'country': 'Czechia', 'facility': 'University of Ostrava, Faculty of Medicine', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}], 'centralContacts': [{'name': 'Jana Soldánová', 'role': 'CONTACT', 'email': 'jana.soldanova@osu.cz', 'phone': '+420553462823'}], 'overallOfficials': [{'name': 'Marek Bužga, Doc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ostrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ostrava', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute for Clinical and Experimental Medicine', 'class': 'OTHER_GOV'}, {'name': 'Vitkovice Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}