NCT05599477: GATE

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

Status unknown Phase 2 Last updated 31 October 2022

What this trial tests

Phase 2 trial testing Endoscopic sutured gastroplasty with endomina in Diabete Type 2 in 40 participants. Status unknown.

Timeline

1 December 2022

Primary endpoint
1 June 2025

1 September 2025

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 December 2022
Primary completion	1 June 2025
Estimated completion	1 September 2025

Drugs / interventions tested

• Endoscopic sutured gastroplasty with endomina

Conditions studied

• Diabete Type 2 — all drugs for Diabete Type 2 →
• Obesity — all drugs for Obesity →

Sponsor

Radboud University Medical Center

Who can join

Adults 18 to 65, any sex, with Diabete Type 2 or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.