Type 2 Diabetes Mellitus (T2D)MEASURENCT07639684
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
A study testing ESG with OverStitch in people with Type 2 Diabetes Mellitus (T2D) and Obesity (BMI>30), run by Boston Scientific Corporation.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
- What is being tested?
- ESG with OverStitch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2027to Jul 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Meets the indications for ESG procedure with OverStitch™ or OverStitch NXT™ Endoscopic Suturing System, excluding the following but not limited to the following: large hiatal hernia, potential bleeding gastric lesions (e.g. ulcers; erosive gastritis; varices; or vascular malformation), coagulopathy and antiplatelet/anticoagulant therapy that cannot be corrected
- 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.
Who cannot join
- 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 medication regime for diabetic management
- More than one episode of clinically significant reactive or severe hypoglycemia within the prior 1 year. Reactive hypoglycemia is defined as postprandial hypoglycemia meeting Whipple's Triad; severe hypoglycemia is defined as any hypoglycemic episode requiring assistance from another person to administer carbohydrates, glucagon, or other corrective/resuscitative action
- History of ketoacidosis or hyperosmolar nonketotic coma within the past 1 year
- Has a contraindication for ESG procedure with OverStitch™ or OverStitch NXT™ Endoscopic Suturing System, including but not limited to the following: large hiatal hernia, potential bleeding gastric lesions (e.g. ulcers; erosive gastritis, varices, or vascular malformation), coagulopathy and antiplatelet/anticoagulant therapy that cannot be correct
- Prior gastric surgery, including but not limited to LSG or RYGP
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- Any known conditions that impact weight loss or glycemic management
- Chronic systemic steroids or immunosuppressants taken at the time of enrollment or likely required during the study follow-up
- CKD stage 3+, defined as eGFR < 60 mL/min
- Persistent anemia, defined as hemoglobin < 10 g/dL
- Excessive alcohol consumption, defined as meeting or exceeding sex-based heavy drinking limits
- Use within the last three months prior to screening of over the counter or prescribed weight loss supplements / medications, or intent to use any weight loss medications or supplements during the study duration.
- The investigator's medical judgment that the subject is not a candidate for the ESG procedure due to findings, including but not limited to psychological and nutritional evaluation results obtained in the prior 12 months.
- Current pregnancy confirmed by site standard of care or planned pregnancy or breastfeeding for a year following the ESG procedure.
- Vulnerable subject.
- Current or planned participation in another clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Metabolic Effects of Endoscopic Sleeve Gastroplasty in Obese Adults With Type 2 Diabetes: Evaluation of Glycemic Control, Insulin Use and Obesity Response
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.
- Conditions
- Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
- Being tested
- ESG with OverStitch
- Keywords
- Endoscopic Sleeve Gastroplasty (ESG), OverStitch
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESG with OverStitchDevice
Endoscopic Sleeve Gastroplasty (ESG) with OverStitch Endoscopic Suturing System.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Sleeve Gastroplasty (ESG) Procedure | Experimental | Not described Receives: Device: ESG with OverStitch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
Serious Adverse Events related to the study procedure and/or study device defined as Grade III or greater according to Clavien-Dindo Classification
Measured: Through study completion, 12 months post procedure
Average Change in HbA1c
Mean change in HbA1c from baseline to 1-year. If rescue treatment is initiated, the last HbA1c value before initiation of rescue treatment is used for assessment of the primary effectiveness endpoint.
Measured: 12 months post procedure
Secondary outcomes (1)
Proportion of Subjects Achieving HbA1c < 7%
Proportion of subjects achieving HbA1c < 7% without initiating rescue treatment at 1-year
Measured: 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startApr 2027 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2D)Studies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ildiko Lingvay, MD, Principal investigator, UT SouthwesternShailendra Singh, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639684
- Sponsor's protocol ID
- E7233
- Acronym
- MEASURE
- Status last verified
- Oct 2026
- First submitted
- 28 May 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes