Obesity (BMI>30), Type 2 Diabetes Mellitus (T2D)
Conditions
Keywords
Endoscopic Sleeve Gastroplasty (ESG), OverStitch
Brief 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.
Interventions
DEVICEESG with OverStitch
Endoscopic Sleeve Gastroplasty (ESG) with OverStitch Endoscopic Suturing System.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | Through study completion, 12 months post procedure | Serious Adverse Events related to the study procedure and/or study device defined as Grade III or greater according to Clavien-Dindo Classification |
| Average Change in HbA1c | 12 months post procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Achieving HbA1c < 7% | 12 months post procedure | Proportion of subjects achieving HbA1c \< 7% without initiating rescue treatment at 1-year |
Contacts
CONTACTBridget Stanford
PRINCIPAL_INVESTIGATORIldiko Lingvay, MD
UT Southwestern
PRINCIPAL_INVESTIGATORShailendra Singh, MD
West Virginia University
Outcome results
None listed