Magnetic compression jejunoileal anastomosis for adults with type 2 diabetes

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

This will try using paired magnetic rings placed laparoscopically to create a partial connection between the jejunum and ileum in adults with type 2 diabetes to see if it improves metabolic markers and procedural outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 25 Years to 65 Years
• Sex: All
• Sponsor: iIDEAS Group Holdings Limited (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Ahmedabad, Gujarat)
• Trial ID: NCT07495787 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center, single-arm feasibility study enrolling five adults with type 2 diabetes to test a magnetic compression anastomosis technique. Under general anesthesia, surgeons will place a distal ring in the terminal ileum and a proximal ring in the jejunum using laparoscopic instruments, align the magnets, and confirm coupling with intraoperative imaging. The study will track perioperative safety and metabolic indicators such as HbA1c and other relevant labs over a short follow-up period. The trial is investigator-initiated, planned at a single site in Ahmedabad, India, and will begin after IRB/IEC approval.

Who should consider this trial

Good fit: Ideal candidates are adults 25–65 years old with BMI 25–50, diagnosed type 2 diabetes with HbA1c 7.5–10.5%, currently on oral combination therapy, and with at least 12 months of diabetes self-management experience.

Not a fit: People who are pregnant or breastfeeding, require insulin therapy, have major abdominal surgery or significant comorbidities, or whose HbA1c or BMI fall outside the study ranges are unlikely to benefit from this small feasibility study.

Why it matters

Potential benefit: If successful, the procedure could improve blood sugar control and reduce the need for diabetes medications through a less invasive bypass-like approach.

How similar studies have performed: Traditional bariatric bypass procedures have established metabolic benefits, but creating a jejunoileal connection using magnetic compression is a novel technique with very limited prior human data.

Eligibility criteria

Inclusion Criteria:

* Subjects will be included in the study if they meet the following criteria:

  1. Participant is willing and able to give informed consent for participation in the study.
  2. Male or Female, aged ≥ 25 years to ≤ 65 years.
  3. BMI greater than or equal to 25 and less than 50
  4. 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
  5. 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
  6. Currently taking oral combination therapy for T2DM
  7. At least 12 months of experience with Diabetes Self-Management and Support

Exclusion Criteria:

* 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:

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
15. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
16. Use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure
17. 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)
18. History of serious complications of T2DM including coronary artery disease, hypertension, peripheral vascular disease, diabetic retinopathy, and/or diabetes-related soft tissue infection
19. Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
20. Receiving weight loss medications such as Meridia, Xenical, or over-the-counter weight loss medications
21. Persistent anemia, defined as Hgb\<10 g dL-1
22. Estimated Glomerular Filtration Rate (eGFR) or Modified of Diet in Renal Disease (MDRD) \<30 ml/min/1.73m2
23. Active systemic infection
24. Currently on anticoagulation therapy other than a low-dose aspirin regimen
25. Chemotherapeutic cancer treatment within past 9 months, history of abdominal radiation, or active malignancy within the past 5 years
26. Active illicit substance abuse or alcoholism
27. 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
28. Any other serological markers likely to be associated with poor outcomes

Where this trial is running

Ahmedabad, Gujarat

• AB Plus Speciality Hospital — Ahmedabad, Gujarat, India (Recruiting)

Study contacts

• Study coordinator: Purvi A Chavda, MD

Conditions Diabete Type 2; Magnetic Compression Anastomosis