The GATE Study: Endoscopic Sutured Gastroplasty in Type 2 Diabetic, Obese Patients Using the Endomina Device

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Oct 26, 2022

Keywords

ClinConnect Summary

The GATE Study is a clinical trial exploring a new weight loss treatment called endoscopic sutured gastroplasty using the Endomina device for people who have type 2 diabetes and are obese. This study aims to see if this procedure can help improve blood sugar control in patients who are currently using insulin and have a body mass index (BMI) between 30 and 40. Weight loss can greatly benefit individuals with diabetes, and this trial hopes to offer a solution for those who may not qualify for traditional weight loss surgery.

To be eligible for the study, participants must be between 18 and 65 years old, diagnosed with type 2 diabetes for less than 10 years, and have been on a stable dose of insulin for at least 6 months. They also need to have a specific range of blood sugar levels and a BMI that falls within the designated range. If someone joins the study, they will undergo the gastroplasty procedure, which has been associated with only minor side effects like abdominal cramps and nausea. After the procedure, participants will be monitored for a year through regular follow-up visits to assess their health and quality of life. This study is not yet recruiting participants, but it aims to provide important insights into a potential new treatment for managing diabetes and obesity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 18-65 years;
• • Diagnosed with DM2
• • since at least 1 year
• • but diagnosed no longer than 10 years ago
• • currently under stable dose of insulin for at least 6 months
• • HbA1c level of 7.0-11.0% (53-75 mmol/mol) prior to inclusion
• • BMI of 30-40 kg/m² with or without hypertension
• • Must be able to comply with all study requirements for the duration of the study as outlined in the protocol (including compliance to treatment, dietary follow up, visits as scheduled and all study specific procedures)
• • Must be able to understand and be willing to provide written informed consent
• • Must be eligible for general anesthesia or deep sedation with propofol
• Exclusion Criteria:
• • Achalasia and any other esophageal motility disorders
• • Severe esophagitis (grade C or D)
• • Gastro-duodenal ulcer
• • GI stenosis or obstruction
• • Any history of esophageal or gastric surgery
• • Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity
• • Uncontrolled hypertension (systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>100 mm Hg under medication) during last 3 months;
• • Severe renal, hepatic, pulmonary disease or cancer (cancer in the past 5 years, except basal cell carcinoma)
• • Pregnancy, breast feeding or desire for pregnancy in the coming 12 months
• • Any previous bariatric surgery, or endoscopic obesity-related intervention (including POSE, OverStitch, etc.). Intragastric balloon removed within the last 6 months
• • Planned gastric surgery 60 days post intervention
• • Anticoagulant therapy that cannot be temporarily stopped at the time of the procedure.
• • Currently participating in other study (involving change of treatment) that did not reach its primary endpoint