Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D) (NCT07639684) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
50 participantsStarted 2027-02
Plain-language summary
The goal of this clinical trial is to determine whether Endoscopic Sleeve Gastroplasty (ESG)-induced weight loss can improve glycemic outcomes and alter the trajectory toward insulin dependence in adults with obesity and inadequately controlled Type 2 Diabetes (T2D) despite guideline-directed therapy, including Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA)-based agents.
Who can participate
Age range
22 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:
* Willing and able to provide written informed consent to participate in the study
* Age ≥ 22 years
* BMI 30 - 50 kg/m2
* HbA1c 7.5 - 10.5%
* Type 2 Diabetes treated with incretin-based medication (aka GLP-1RA agonist or GLP-1RA/GIP dual agonist) at a stable, maximal tolerated dose for a minimum of 6 months +/- any other oral glucose lowering medications AND intention to initiate insulin therapy for glycemic management
* Stable weight (\< 5% TBW) within the 3 months prior to screening
* Meets the indications for ESG procedure with OverStitch™ or OverStitch NXT™ Endoscopic Suturing System
* Declines or is ineligible for metabolic bariatric surgery
* Agrees to abstain from taking any weight loss treatments or supplements that are not part of the lifestyle modification program for a year following the ESG procedure
* Willing and able to comply with the study procedure with standard of care lifestyle modification program and visit schedule.
Exclusion Criteria:
* Diabetes management with insulin. Prior use of insulin for gestational diabetes or short-term use (up to 1 month) in conjunction with an acute condition is acceptable.
* Noncompliance with medicatio9n regime for diabetic management
* History of reactive or severe hypoglycemia within the prior 1 year
* History of ketoacidosis or hyperosmolar nonketotic coma within the past 1 year
* Any known conditions that impact weight loss or glycemic management
* Chronic systemic steroids or immunosuppressants ta…
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.
1Since this trial is not yet recruiting, how long might it realistically be before I could actually enroll, and is waiting that long a safe option given my current blood sugar control?
2This study is measuring serious adverse events as a primary outcome — what kinds of serious complications are typically associated with Endoscopic Sleeve Gastroplasty, and how does that risk profile compare to other obesity treatments I could pursue right now?
3The trial is specifically looking at changes in HbA1c — given where my HbA1c currently stands, do you think a procedure like ESG could meaningfully move that number for me, or are there medications or lifestyle programs that might achieve similar results without a procedure?
4This trial lists a Phase of 'NA,' which often means it's evaluating a device or procedure rather than a drug — does that change what protections or unknowns I should be aware of compared to a standard drug trial?
5Since both Type 2 diabetes and a BMI over 30 are required conditions, am I the kind of patient this trial seems designed for, and are there other factors in my health history that might make me a poor fit or put me at higher risk?
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.
What they're measuring
1
Serious Adverse Events
Timeframe: Through study completion, 12 months post procedure