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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
ESG with OverStitch
DeviceEndoscopic Sleeve Gastroplasty (ESG) with OverStitch Endoscopic Suturing System.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Endoscopic Sleeve Gastroplasty (ESG) ProcedureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Through study completion, 12 months post procedure2
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.
Time frame
12 months post procedureSecondary outcomes
1
Proportion of Subjects Achieving HbA1c < 7%
Proportion of subjects achieving HbA1c \< 7% without initiating rescue treatment at 1-year
Time frame
12 months post procedureOther outcomes
1
Weight Loss
Total Body Weight Loss (TBWL) % and Excess Weight Loss (EWL) % at each visit
Time frame
1, 3, 6, 9, and 12 months post procedure2
Proportion of Subjects with a Total Body Weight Loss ≥ 10%
Proportion of subjects with a TBWL ≥ 10% at each visit
Time frame
1, 3, 6, 9, and 12 months post procedure3
Proportion of Subjects Achieving HbA1c < 6.5%
Proportion of subjects achieving HbA1c \< 6.5% without initiating rescue treatment at 1-year
Time frame
12 months post procedure4
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
Time frame
12 months post procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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