Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Sleeve Gastroplasty (ESG) Procedure | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESG with OverStitch | Device | Endoscopic Sleeve Gastroplasty (ESG) with OverStitch Endoscopic Suturing System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | Serious Adverse Events associated with 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieving HbA1c < 7% | Proportion of subjects achieving HbA1c < 7% without initiating rescue treatment at 1-year | 12 months post procedure |
| 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 |
| Number of Subjects with a Total Body Weight Loss ≥ 10% | Proportion of subjects with a TBWL ≥ 10% at each visit |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bridget Stanford | Contact | 781-305-0506 | bridget.stanford@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Ildiko Lingvay, MD | UT Southwestern | Principal Investigator |
| Shailendra Singh, MD | West Virginia University | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1, 3, 6, 9, and 12 months post procedure |
| Number of Subjects Achieving HbA1c < 6.5% | Proportion of subjects achieving HbA1c < 6.5% without initiating rescue treatment at 1-year | 12 months post procedure |
| Number of Subjects Achieving TBWL ≥ 10% AND HbA1c < 7% | Proportion of subjects with a TBWL ≥ 10% AND a HbA1c < 7% without initiating rescue treatment at 1-year | 12 months post procedure |
| Number 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 |
| Number 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 |
| Number of Subjects with Improvement in Comorbidities | Proportion of subjects with improvement in obesity-related comorbidities from baseline to 1-year: Hypertension, Dyslipidemia, Obstructive sleep apnea, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) | 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 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 |
| 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 |
| Change in Quality of Life | Change in quality of life, as assessed by 36-Item Short Form Health Survey (SF-36), from baseline to 1-year; Higher scores indicate a better, higher quality of life and fewer health-related limitations. | 12 months post procedure |
| Adverse Events | Adverse events associated with study procedure and/or study device | Through study completion, 12 months post procedure |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |