Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
iEMIS HK Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants are willing and able to give informed consent for participation in the study. 2. Male or Female, aged 25 years to 65 years inclusive at the time of informed consent 3. BMI 30-50 Prior sleeve gastrectomy (more than 12 months) or other metabolic surgical procedures with T2DM (characterized by HbA1c more than 6.5%) or weight regain T2DM without a history of gastrectomy or other metabolic surgical procedures (diagnosis for more than 6M and less than 10 yrs) taking at least oral antidiabetic medication with fasting glucose less than 200mg/dl and HbA1c greater than 6.5 % 4. Agrees to abstain from any form of additional bariatric or reconstructive surgery that could influence body weight for a duration of 1 year 5.Able to comply with protocol requirements
Exclusion criteria
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. Use of injectable insulin 5. Uncontrolled T2DM 6. Uncontrolled hypertension, dyslipidemia, or sleep apnea 7. Current history of injected Glucagon Like Peptide 1 (GLP1) 8. 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 9. History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging 10. Previous intestinal, colonic, or duodenal surgery, excluding bariatric procedures 11. Prior surgical interventions, trauma, prosthetic implants, diseases, or genetic factors that hinder or contraindicate the procedure, including scarring and abnormal anatomical structures 12. History of (or known to be at prohibitive risk for) any of the following diseases of the small bowel or closely related conditions: Crohns disease or other inflammatory bowel disease, celiac disease, resection for cancer, or intra-abdominal adhesive disease including intussusception, perforated appendix and Meckels diverticulum 13. Refractory gastroesophageal reflux disease (GERD) 14. Barretts esophagus 15. Any anatomical anomaly that obstructs orogastric access via gastroscope and catheters, as well as manipulation techniques 16. Presence of an implantable pacemaker or defibrillator 17. Any comorbidity or current physiological condition of the subject that, in the opinion of the surgeon or anesthesiologist, poses safety concerns rendering the subject medically unfit for the procedure. This encompasses any conditions for which endoscopic or laparoscopic surgery would be contraindicated, as well as any significant congenital or acquired anomalies of the gastrointestinal tract at or distal to the magnet placement site 18. History of small bowel surgery such as small bowel resection 19. 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.) 20. History of chronic or acute pancreatitis 21. Known active hepatitis or active liver disease 22. Symptomatic gallstones or kidney stones or acute cholecystitis 23. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia 24. Use of anticoagulation therapy (excluding aspirin) which cannot be discontinued for 7 days before and 14 days after the procedure 25. 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) 26. History of serious complications of T2DM including coronary artery disease, hypertension, peripheral vascular disease, diabetic retinopathy, and/or diabetes-related soft tissue
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Feasibility and performance evaluated by the success of the partial jejuno-ileal diversion 2.Safety Profile Timepoint: 1.Feasibility and performance evaluated by the success of the partial jejuno-ileal diversion procedure 2.Safety Profile | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Weight loss Efficacy in terms of weight loss based on the change from baseline in total weight loss (Percent TWL) & excess weight loss (Percent EWL) to be assessed at 3 months, 6 months, 9 months & at 12 months following the index procedure 2 Metabolic Improvements To observe changes in glycosylated hemoglobin A1c levels & blood glucose at the baseline with the HbA1c levels measured at 3 months, 6 months, 9 months & at 12 months following the index procedureTimepoint: be assessed at 3 months, 6 months, 9 months & at 12 months following the index procedure | — |
Countries
India
Contacts
Public ContactDr Mahendra Narwaria
AB Plus super speciality Hospital
Outcome results
None listed