Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D) (MEASURE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes Mellitus (T2D); Obesity (BMI>30)
• Intervention / Treatment: Device: ESG with OverStitch

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bridget Stanford; Phone Number: 781-305-0506; Email: bridget.stanford@bsci.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, 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.

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 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic Sleeve Gastroplasty (ESG) Procedure	Device: ESG with OverStitch; Endoscopic Sleeve Gastroplasty (ESG) with OverStitch Endoscopic Suturing System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months post procedure
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	Through study completion, 12 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Achieving HbA1c < 7%	Proportion of subjects achieving HbA1c < 7% without initiating rescue treatment at 1-year	12 months post procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss	Total Body Weight Loss (TBWL) % and Excess Weight Loss (EWL) % at each visit	1, 3, 6, 9, and 12 months post procedure
Change in Vitals	Change in vitals from baseline to 6-months and from baseline to 1-year: Systolic blood pressure, Diastolic blood pressure	6 and 12 months post procedure
Change in Blood Laboratory Tests	Change in blood laboratory tests from baseline to 6-months and from baseline to 1-year: fasting plasma glucose, estimated glomerular filtration rate (eGFR), aspartate aminotransferase (AST), alanine aminotransferase (ALT,) low-density lipoprotein cholesterol (LDL-C), Triglycerides	6 and 12 months post procedure
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	Change in HOMA-IR from baseline to 6-months and from baseline to 1-year	6 and 12 months post procedure
Change in Fibrosis-4 (FIB-4)	Change in FIB-4 from baseline to 6-months and from baseline to 1-year	6 and 12 months post procedure
Change in Nonalcoholic Fatty Liver Disease (NAFLD) Fibrosis Score	Change in NAFLD Fibrosis Score (NFS) from baseline to 6-months and from baseline to 1-year	6 and 12 months post procedure
Change in Diabetes Self-Care Activity	Change in diabetes self-care activity, as assessed by Summary of Diabetes Self-Care Activity (SDSCA), from baseline to 6-months and from baseline to 1-year; Higher scores indicate better compliance with diabetic self-care recommendations. Lower scores point to areas where the patient may be struggling or may need additional education and support.	6 and 12 months post procedure
Adverse Events	Adverse events associated with study procedure and/or study device	Through study completion, 12 months post procedure
Change in Diabetes Treatment Satisfaction	Change in diabetes treatment satisfaction, as assessed by Diabetes Treatment Satisfaction Questionnaire - status (DTSQs), from baseline to 1-year and Diabetes Treatment Satisfaction Questionnaire - change (DTSQc) at 1-year; Positive score indicates an improvement in satisfaction, or a reduction in the frequency of hyper/hypoglycemia. Negative score indicates a deterioration in satisfaction, or an increase in the frequency of hyper/hypoglycemia. Zero indicates no change in satisfaction or symptoms.	12 months post procedure
Proportion of Subjects with a Total Body Weight Loss ≥ 10%	Proportion of subjects with a TBWL ≥ 10% at each visit	1, 3, 6, 9, and 12 months post procedure
Proportion of Subjects Achieving HbA1c < 6.5%	Proportion of subjects achieving HbA1c < 6.5% without initiating rescue treatment at 1-year	12 months post procedure
Proportion of Subjects Achieving TBWL ≥ 10% AND HbA1c < 6.5%	Proportion of subjects with a TBWL ≥ 10% AND a HbA1c < 6.5% without initiating rescue treatment at 1-year	12 months post procedure
Proportion of Subjects Initiating Rescue Treatment	Proportion of subjects initiating rescue treatment at any time during the study follow-up period	Through study completion, 12 months post procedure
Proportion of Subjects Meeting Rescue Criteria	Proportion of subjects meeting rescue criteria at any time during the study follow-up period	Through study completion, 12 months post procedure
Proportion of Subjects with Improvement in Comorbidities	Proportion of subjects with improvement in each specific obesity-related comorbidity, as applicable, from baseline to 1-year: Hypertension, Dyslipidemia, Obstructive sleep apnea, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)	12 months post procedure
Change in Quality of Life	Change in quality of life, as assessed by 36-Item Short Form Health Survey (SF-36) domain scores and Physical and Mental Component Summaries (PCS and MCS), from baseline to 1-year; Higher scores indicate a better, higher quality of life and fewer health-related limitations.	12 months post procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Shailendra Singh, MD, West Virginia University; Principal Investigator: Ildiko Lingvay, MD, Ut Southwestern

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 20, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Endoscopic Sleeve Gastroplasty (ESG); OverStitch
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2
• Other Study ID Numbers: E7233

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No