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

Boston Scientific

Status

Begins enrollment in 7 months

Conditions

Obesity (BMI>30)

Type 2 Diabetes Mellitus (T2D)

Treatments

Device: ESG with OverStitch

Study type

Interventional

Funder types

Industry

Identifiers

NCT07639684

E7233

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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 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.