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

Radboud University Medical Center

Status and phase

Not yet enrolling

Phase 2

Conditions

Obesity

Diabete Type 2

Treatments

Device: Endoscopic sutured gastroplasty with endomina

Study type

Interventional

Funder types

Other

Identifiers

NCT05599477

NL82297.091.22

Details and patient eligibility

About

Rationale: Diabetes mellitus is a chronic disease that is often associated with long-term macrovascular and microvascular complications and decreased life expectancy. Approximately 70% of patients with type 2 diabetes mellitus (DM2) are overweight or obese. Weight loss benefits several aspects of DM2, such as improved glycemic control, increased insulin sensitivity and reduced fasting insulin. This results in a reduction in glycated hemoglobin. Interventions for weight loss in patients with DM2 include diet, exercise, but also pharmacotherapy and bariatric surgery. Current standard pharmacotherapeutic treatment for patients with DM2 in the Netherlands starts with metformin, followed by insulin. Bariatric surgery is indicated at a BMI > 35 kg/m², in combination with other comorbidities. It is associated with better glycemic control and more weight reduction, compared to intensive medical treatment alone. For patients with not adequately controlled DM2 who are not eligible for surgery (i.e., BMI of < 35 kg/m²), there is currently a therapeutic gap, which could be filled by one of the currently available endoscopic therapies aiming to reduce weight. One of these therapies is endoscopic suture gastroplasty, performed with the endomina device (EndoTools Therapeutics S.A.).

Objective: To evaluate the efficacy and safety of endoscopic sutured gastroplasty with the endomina device (EndoTools Therapeutics S.A.) for glycemic control, in obese patients (BMI of 30-40 kg/m²) with DM2 under insulin therapy with or without hypertension.

Study design: Prospective interventional study Study population: All consecutive patients, with a BMI between 30 and 40 kg/m² with DM2 for less than 10 years, treated with insulin therapy.

Intervention: Endoscopic suture gastroplasty will be performed using the endomina device.

Main study parameters/endpoints: Reduction of 0.7% in HbA1C after 1 year post procedure.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will undergo endoscopic suture gastroplasty using endomina, which is known with only minor adverse events (abdominal cramps, nausea, vomiting), and a serious adverse events so far of > 1% (one readmission, no surgical intervention needed, no mortality). Afterwards, patients will be followed at 14 days, 1 month, and 3, 6, 9 and 12 months after gastroplasty for clinical and adverse event assessment. Clinical assessment consists of laboratory tests and the quality-of-life questionnaire (EQ-5D-5L), and Diabetes Treatment Satisfaction Questionnaire as well as Quality adjusted life years.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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