Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorBoston Scientific Corporation
About this trial
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.
Eligibility criteria
Qualifiers
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%
Disqualifiers
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
Trial design
Treatments tested in this trial
- ESG with OverStitch
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov