Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With … (NCT06267391) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes
United States, Australia350 participantsStarted 2024-05-01
Plain-language summary
This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.
Who can participate
Age range
22 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 22- 70 years of age, inclusive.
* T2D diagnosis for at least 6 months.
* HbA1C of 7.5-10.5%, inclusive, determined by the central laboratory.
* BMI 27-40 kg/m2, inclusive.
* On 2-4 non-insulin glucose lowering mediations or on monotherapy with either GLP-1 or GLP-1/GIP medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit.
* Individualized metabolic surgery (IMS) score ≤ 95.
* Weight stability (≤5% weight change) for at least 12 weeks prior to the screening visit.
* Agree not to donate blood during participation in the study.
* Able to comply with study requirements and understand and sign the Informed Consent Form.
* Women of childbearing potential must be not pregnant and using an acceptable method of contraception throughout the study.
* Willing and able to comply with study visits and study tasks as required per protocol.
Exclusion Criteria:
* Diagnosed with type 1 diabetes.
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
* Fasting serum C-peptide \<1 ng/mL (333pmol/l).
* Current use of insulin, or previous use of any types of insulin for \>1 month at any time (except for treatment of gestational diabetes) in last 2 years.
* Hypoglycemic unawareness.
* History of ≥1 severe hypoglycemia episode in past 6 months
* Discontinuation of a GLP-1RA or a GLP-1/GIP dual-agonist within 6 months of the screening visit following at least one month of treatment.
* Known autoimmune disease, inc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing something called 'Endoscopic Intestinal Re-Cellularization Therapy' — can you explain what that procedure actually involves, and what physical risks come with an endoscopic procedure for someone in my situation?
2Since this trial is listed as Phase NA, which often means it's a device or procedure study rather than a standard drug trial, how does that affect what we currently know about its safety and long-term effectiveness for managing Type 2 diabetes?
3The trial is actively enrolling but no longer recruiting new participants — does that mean there's any chance I could still be considered, or should we focus on other options right now?
4The main thing this trial is measuring is HbA1c improvement — based on what you know about this approach, how does that potential benefit compare to adjusting my current diabetes medications or other established treatments?
5How does this intestinal re-cellularization approach differ from other procedural options for Type 2 diabetes, like gastric procedures, and would any of those be worth discussing as alternatives given where my HbA1c currently stands?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.