Magnetic Compression Anastomosis Procedure for Partial Jejunoileal Anastomosis: Assessing the Viability of an Innovative Metabolic Approach

Prior treatment

• Current enrolment in another research study or previous participation within 30 days of enrolment
• Use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure
• Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure (use of low-dose aspirin allowable)
• Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
• Receiving weight loss medications such as Meridia, Xenical, or over-the-counter weight loss medications
• Currently on anticoagulation therapy other than a low-dose aspirin regimen
• Known sensitivity to possible medications used before, during, or after the Connect procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics

Other illness

• Current history of injected Glucagon Like Peptide 1 (GLP1)
• Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)
• History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging
• History of (or known to be at prohibitive risk for) any of the following diseases of the small bowel or closely related conditions: Crohn's disease or other inflammatory bowel disease, celiac disease, resection for cancer, or intra-abdominal adhesive disease including intussusception, perforated appendix and Meckel's diverticulum
• History of small bowel surgery such as small bowel resection
• Active H. pylori infection (prospective participants with active H. pylori may continue with the screening process if they are treated via medication and re-testing verifies the condition has resolved.)
• History of chronic or acute pancreatitis
• Known active hepatitis or active liver disease
• History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
• History of serious complications of T2DM including coronary artery disease, hypertension, peripheral vascular disease, diabetic retinopathy, and/or diabetes-related soft tissue infection
• Active systemic infection
• Chemotherapeutic cancer treatment within past 9 months, history of abdominal radiation, or active malignancy within the past 5 years

Lab values

• 1\. Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months 2. Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.) 3. Current enrolment in another research study or previous participation within 30 days of enrolment 4. Current history of injected Glucagon Like Peptide 1 (GLP1) 5. American Society of Anesthesiologists (ASA) physical classification level of 4 or greater 6. Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year) 7. Evidence of type 1 diabetes or of pancreatic exhaustion, as indicated by a C peptide fasting level less than 1 or, for type 1 diabetes, based on measurable levels of serum anti-GAD-65 autoantibodies or, at investigator's discretion, based on measurable levels of other T1D-associated autoantibodies 8. History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging 9. History of (or known to be at prohibitive risk for) any of the following diseases of the small bowel or closely related conditions: Crohn's disease or other inflammatory bowel disease, celiac disease, resection for cancer, or intra-abdominal adhesive disease including intussusception, perforated appendix and Meckel's diverticulum 10. History of small bowel surgery such as small bowel resection 11. Active H. pylori infection (prospective participants with active H. pylori may continue with the screening process if they are treated via medication and re-testing verifies the condition has resolved.) 12. History of chronic or acute pancreatitis 13. Known active hepatitis or active liver disease 14. Symptomatic gallstones or kidney stones or acute cholecystitis
  • Subjects will be deemed ineligible to participate if they fulfill any of the following criteria:
• Evidence of type 1 diabetes or of pancreatic exhaustion, as indicated by a C peptide fasting level less than 1 or, for type 1 diabetes, based on measurable levels of serum anti-GAD-65 autoantibodies or, at investigator's discretion, based on measurable levels of other T1D-associated autoantibodies
• Estimated Glomerular Filtration Rate (eGFR) or Modified of Diet in Renal Disease (MDRD) \<30 ml/min/1.73m2

Other

• Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months
• Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
• American Society of Anesthesiologists (ASA) physical classification level of 4 or greater
• Symptomatic gallstones or kidney stones or acute cholecystitis
• Persistent anemia, defined as Hgb\<10 g dL-1
• Active illicit substance abuse or alcoholism
• Any other serological markers likely to be associated with poor outcomes

• Subjects will be included in the study if they meet the following criteria:
  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged ≥ 25 years to ≤ 65 years.
  • BMI greater than or equal to 25 and less than 50
  • Clinical diagnosis of T2DM by plasma glucose criteria, either the fasting plasma glucose (FPG) value or the 2-h plasma glucose (2-h PG) value during a 75-g oral glucose tolerance test (OGTT), or A1C criteria
  • Glycated Hemoglobin greater than or equal to 7.5% and less than 10.5% in at least one laboratory analysis conducted within the past 3 months, typically associated with a recommendation by patient's primary care physician and/or endocrinologist for intensification of treatment beyond oral medications
  • Currently taking oral combination therapy for T2DM
  • At least 12 months of experience with Diabetes Self-Management and Support