Clinical trial NCT05599477: The GATE Study: Endoscopic Sutured Gastroplasty in Type 2 Diabetic, Obese Patients Using the Endomina Device
Official title: The GATE Study: Endoscopic Sutured Gastroplasty in Type 2 Diabetic, Obese Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Diabete Type 2
Obesity
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Endotools Therapeutics
First posted: 2022-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Reduction in HbA1c
timeFrame: 1 year
Secondary outcomes:
measure: Rate of Serious Adverse Events (SAE) and Serious Adverse Device Effects (SADE) during and post procedure
timeFrame: 1 year
measure: Adverse events up to 1-month follow-up for subjects undergoing the procedure under procedural sedation with propofol
timeFrame: 1 year
measure: Cardiovascular events (stroke/TIA, myocardial infarction, admission for heart failure) and all-cause mortality
timeFrame: 1 year
measure: Reduction of HbA1C at 14 days, 1 month, 3, 6, and 9 months after ESG
timeFrame: 1 year
measure: Reduction in fasting plasma glucose levels at 14 days, 1 month, 3, 6, 9 and 12 months after ESG
timeFrame: 1 year
measure: Proportion of subjects with reduced number and/or reduced dose(s) of diabetes medication at 14 days, 1 month, 3, 6, 9 and 12 months after ESG
timeFrame: 1 year
measure: Proportion of subjects with mean % excess weight loss (EWL) of more than 25% at 14 days, 1 month, 3, 6, 9 and 12 months after ESG
timeFrame: 1 year
measure: Proportion of subjects with mean % total body weight loss (TBWL) of more than 5% at 14 days, 1 month, 3, 6, 9 and 12 months after ESG
timeFrame: 1 year
measure: Decrease in blood pressure expressed in mmHg at 14 days, 1 month, 3, 6, 9 and 12 months after ESG
timeFrame: 1 year
measure: EQ-5D-5L at 14 days, 1 month, 3, 6 and 12 months after ESG
timeFrame: 1 year
measure: Diabetes Treatment Satisfaction Questionnaire at 14 days, 1 month, 3, 6, 9 and 12 months after ESG
timeFrame: 1 year
measure: Quality adjusted life years (QALYs)
timeFrame: 1 year
measure: Costs and cost-effectiveness.
timeFrame: 1 year
Other outcomes:
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