Magnetic gut reroute shows promise for diabetes and weight loss
NCT ID NCT05692518
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new magnetic system that creates a shortcut in the small intestine to help people with obesity and type 2 diabetes. Fifteen adults aged 18-65 with a BMI of 30-35 and diabetes took part. The goal was to see if the device could safely create a lasting connection in the gut to improve diabetes control and weight loss.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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15 people
The number who actually took part.
- Started
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Dec 2022
- Finished
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May 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 18-65 years of age, inclusive, at the time of informed consent 2. BMI 30-35 kg/m2 3. Type 2 diabetes mellitus (T2DM), defined as HbA1c \> 6.5%, without previous sleeve gastrectomy, and without plan to perform a concurrent sleeve gastrectomy. 4. Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study 5. If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study 6. Willing and able to comply with protocol requirements Exclusion Criteria: 1. Type 1 diabetes 2. Use of injectable insulin 3. Uncontrolled T2DM 4. Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure 5. Uncontrolled hypertension, dyslipidemia or sleep apnea 6. Prior intestinal, colonic or duodenal surgery, other than bariatric 7. Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contra-indicate the procedure, including scarring and abnormal anatomy. 8. Refractory gastro-esophageal reflux disease (GERD) 9. Barrett's disease 10. Helicobacter pylori positive and/or active ulcer disease 11. Large hiatal hernia 12. Inflammatory bowel or colonic diverticulitis disease 13. Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques. 14. Implantable pacemaker or defibrillator 15. Psychiatric disorder, except well-controlled depression with medication for \> 6 mo 16. History of substance abuse 17. Woman who is either pregnant or breast feeding 18. Woman of childbearing potential who does not agree to use an effective method of contraception. 19. Any comorbidity or current status of subject's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the subject medically unfit for the procedure. 20. Any anomaly preventing/contraindicating laparoscopic access and general laparoscopic procedures 21. Had surgical or interventional procedure within 30 days prior to procedure 22. Any scheduled surgical or interventional procedure planned within 30 days post-procedure 23. Any stroke/transient ischemic attack (TIA) within 6 months prior to consent 24. Requires chronic anticoagulation therapy (except aspirin) 25. Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure 26. Unable to comply with the follow-up schedule and assessments 27. Recent tobacco or nicotine product cessation within \< 3 months prior to informed consent 28. Known allergies to the device components or contrast media 29. Limited life expectancy due to terminal disease 30. Currently participating in another clinical research study with an investigational drug or medical device 31. A positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 or COVID-19) test prior to the study procedure in accordance with local COVID-19 protocol 32. Any condition that, in the investigator's opinion, may preclude completion of follow-up assessments through Day 360 (e.g., a medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, or poor compliance with treatment regimen)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Innova Medical Center
Tbilisi, Georgia, N.6, Georgia
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