Small Bowel Diversion

Obesity Clinical Trial

Official title:

Jejuno-ileal and Jejuno-colic Diversion as a New Bariatric Method in Treatment Diabetes and Obesity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06374368
• Other study ID #: JID-SURG
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65 years at screening;
• Body mass index =30 or =50kg/m2;
• 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;
• If on no diabetes medications, Hemoglobin A1C between and including 6.5 and 9.0 at time of enrollment.

Exclusion Criteria:

• Body Mass Index >50 or <30 kg/m2;
• Diagnosis of Type 2 diabetes less than 6 months;
• History of suspected gastrointestinal disease (for example cirrhosis, inflammatory bowel disease);
• History of active malignancy (not in remission) with the exception of squamous or basal cell carcinoma of the skin;
• Ongoing systemic infection;
• Chronic pancreatitis;
• Chronic liver disease of any cause;
• Poorly controlled psychiatric disease (for example ongoing major depression, schizophrenia, borderline personality, suicidality, psychosis);
• Any history of an eating disorder within the past 5 years;
• Pre-existing severe comorbid cardio-respiratory disease (for example congestive heart failure, cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease, pulmonary embolism);
• uncontrolled hypertension (systolic Blood Preassure > 150 mm Hg or diastolic Blood Preassure > 100 mm Hg).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type2 Diabetes

Intervention

Procedure:
• jejuno-ileal 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).
• 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 anastomosis is created between jejunum (45 from ligament of Treitz) and transverse colon (behind the liver flexure).

Locations

Country	Name	City	State
Czechia	University of Ostrava, Faculty of Medicine	Ostrava

Sponsors (3)

Lead Sponsor	Collaborator
University of Ostrava	Institute for Clinical and Experimental Medicine, Vitkovice Hospital

Country where clinical trial is conducted

Czechia, 

References & Publications (21)

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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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total body weight loss	Weight change in percentage	36 months
Primary	Glycated hemoglobin loss	Glycated hemoglobin change in blood	36 months
Primary	Diabetes medication loss	Reduction in diabetes medication requirements (for diabetic cohort) - absolute value	36 months
Primary	Total cholesterol loss	Total cholesterol loss in blood	36 months
Primary	Low density lipoprotein loss	Low density lipoprotein loss in blood	36 months
Primary	High density lipoprotein loss	High density lipoprotein loss in blood	36 months
Primary	Leptin metabolism evaluation	Leptin value increase/decrease in blood	36 months
Primary	Adiponectin metabolism evaluation	Adiponectin value increase/decrease in blood	36 months
Primary	Bile acids metabolism evaluation	Bile acids value increase/decrease in blood	36 months
Secondary	Change from baseline quality of life-Lite	Questionary "Weight on Quality of Life-Lite (IWQOL-Lite)"	36 months
Secondary	Change from baseline quality of life - Sort Form Survey	Questionary "36-Item Short Form Survey (SF-36)"	36 months