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Could a gut zapping procedure free diabetics from insulin?
NCT ID NCT06655740
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tests a device that uses radiofrequency vapor to ablate (remove) a thin layer of the duodenum (the first part of the small intestine) in 16 adults with type 2 diabetes who need insulin. The goal is to see if this procedure, with or without the drug semaglutide, is safe and can help patients stop insulin therapy while keeping blood sugar under control. Participants will be followed for about 6 months to check safety and whether they remain insulin-free with an HbA1c of 7.5% or lower.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RF vapor ablation device and semaglutide
- What this could lead to
- If successful, this could offer a non-drug procedure to help some type 2 diabetes patients stop insulin injections, possibly combined with semaglutide.
- What could go wrong
- This is a very small early pilot study (16 people) with no control group. The procedure involves ablating part of the gut, which carries risks like bleeding or infection. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
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
-
About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2024
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
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. Adults ≥18 years old but ≤ 65 years old. (Women of childbearing potential must be using one acceptable methods of contraception throughout the study.) 2. Diagnosed with type 2 diabetes mellitus for ≥1 year but ≤ 8 years duration. 3. Glycated haemoglobin ≤ 8.0% (64 mmol/mol). 4. Fasting serum C-peptide ≥ 0.6 ng/mL. 5. Body mass index ≥ 27.5 and ≤ 42.5 kg/m2. 6. On a daily insulin (basal or combined with short-acting) for at least three months, with a dose ≤ 0.6 U/kg, with a stable dose (≤ 20%) over the last month. 7. Able to comply with study requirements and understand and sign the informed consent form. Exclusion Criteria: 1. Diagnosis of Type 1 diabetes mellitus 2. Any history of diabetic ketoacidosis or hyperosmolar nonketotic coma 3. Current use of insulin pump. 4. Current, or within the last 3 months, use of a GLP-1 analogue. 5. Current use of a long-acting sulphonylureas (e.g. glibenclamide, chlorpropamide, glimepiride, glyburide) 6. History of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party assistance, in the last year). 7. Known autoimmune disease, including but not limited to celiac disease, duodenal Crohn disease or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other systemic autoimmune connective tissue disorder. 8. Previous gastrointestinal surgery that could limit treatment of the duodenum such as Billroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions. (Prior laparoscopic sleeve gastrectomy (LSG) will not be an exclusion). 9. History of pancreatitis (acute or chronic). 10. Known diabetic gastroparesis. 11. Persistent anaemia, defined as haemoglobin ≤ 9 g/dL 12. Known active hepatitis or active liver disease. 13. Acute gastrointestinal illness in the previous 7 days. 14. Known history of severe irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease. 15. Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic procedure, including moderate-severe (Grade C or D) esophagitis, dysphagia due to achalasia or stricture/stenosis, esophageal varices, esophageal perforation, or any other disorder of the esophagus. 16. Upper gastrointestinal conditions such as active ulcers, polyps, varices, strictures, congenital or acquired duodenal telangiectasia. 17. Current use of anticoagulation therapy (e.g. warfarin) or direct-acting oral anticoagulants (e.g. rivaroxaban, apixaban, edoxaban and dabigatran) that cannot be discontinued for 3-5 days before and 7 days after the procedure. 18. Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 5 days before and 7 days after the procedure. 19. Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of acetaminophen and low dose aspirin is allowed. 20. Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the baseline visit. 21. Use of drugs known to affect gastrointestinal motility (e.g. Metoclopramide) 22. Use of weight loss medications such as Sibutramine (e.g. Meridia), Orlistat (e.g. Xenical), Phentermine or over-the-counter weight loss medications (prescription medication) 23. Significant cardiovascular disease, including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack, or stroke within 6 months prior to the Screening Visit. 24. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. 25. Uncontrolled thyroid disease 26. Mean of 3 separate blood pressure measurements \>180 mmHg (systolic) or \>100 mmHg (diastolic). 27. Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 (estimated by MDRD). 28. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator. 29. Active illicit substance abuse or alcoholism (\>2 drinks/day regularly) 30. Active malignancy within the last 5 years (excluding non-melanoma skin cancers) 31. Active systemic infection 32. Women who are currently breastfeeding. 33. Pregnancy or wish to get pregnant in the next year. 34. Participating in another ongoing clinical trial of an investigational drug or device. 35. Any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation. 36. Critically ill or has a life expectancy \< 3 years. 37. Use of heart pacemaker or other electronic device implants 38. General contraindications to deep or conscious sedation, general anesthesia, high risk as determined by anesthesiologist (e.g., ASA score 4 or higher), or contraindications to upper GI endoscopy.
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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
-
Clinica Colonial
Santiago, Chile
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