Diabete Type 2Phase 2GATENCT05599477
The GATE Study: Endoscopic Sutured Gastroplasty in Type 2 Diabetic, Obese Patients Using the Endomina Device
A Phase 2 study testing Endoscopic sutured gastroplasty with endomina in people with Diabete Type 2 and Obesity, run by Radboud University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabete Type 2, Obesity
- What is being tested?
- Endoscopic sutured gastroplasty with endomina
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: The GATE Study: Endoscopic Sutured Gastroplasty in Type 2 Diabetic, Obese Patients
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.
Read more
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.
- Conditions
- Diabete Type 2, Obesity
- Being tested
- Endoscopic sutured gastroplasty with endomina
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sutured gastroplasty with endominaDevice
Also called Endoscopic sleeve gastroplasty
The endomina is is used to perform endoscopic sutured gastroplasty. Two guidewires are introduced via an upper GI endoscopy down to the duodenum. The endomina system is introduced and the endoscope is inserted and fixed to the system. Next a needle preloaded with suture is introduced into the platform. The stomach wall is grasped with a forceps and pulled back. The needle is pushed through the wall, and a first tag is released. The needle is retracted, the first plicature is released and a second plicature is made with the same needle at the opposite wall. Then the pretied knot is grasped and tightened until both plicatures are firmly apposed. The same procedure is repeated along the great curvature from the incisura to the upper body.
The procedure will include the placement of 6-9 sutures. The first suture is done at the level of the incisura, at the lower part of the greater curvature. The following stitches are placed along the body of the stomach
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic sutured gastroplasty | Experimental | Not described Receives: Device: Endoscopic sutured gastroplasty with endomina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in HbA1c
a reduction of HbA1C of at least 0.7%
Measured: 1 year
Secondary outcomes (13)
Rate of Serious Adverse Events (SAE) and Serious Adverse Device Effects (SADE) during and post procedure
Measured: 1 year
Adverse events up to 1-month follow-up for subjects undergoing the procedure under procedural sedation with propofol
Measured: 1 year
Cardiovascular events (stroke/TIA, myocardial infarction, admission for heart failure) and all-cause mortality
Measured: 1 year
Reduction of HbA1C at 14 days, 1 month, 3, 6, and 9 months after ESG
Measured: 1 year
Reduction in fasting plasma glucose levels at 14 days, 1 month, 3, 6, 9 and 12 months after ESG
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
Decrease in blood pressure expressed in mmHg at 14 days, 1 month, 3, 6, 9 and 12 months after ESG
Measured: 1 year
EQ-5D-5L at 14 days, 1 month, 3, 6 and 12 months after ESG
Measured: 1 year
Diabetes Treatment Satisfaction Questionnaire at 14 days, 1 month, 3, 6, 9 and 12 months after ESG
Measured: 1 year
Quality adjusted life years (QALYs)
Measured: 1 year
Costs and cost-effectiveness.
Costs including health care recourses used (including intervention including endomina device and TAPES, hospital admissions, visits to specialists and GP, emergency room visits, medications used), costs for insulin therapy (including medication, administration, glycemia measurement material)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Endotools Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599477
- Sponsor's protocol ID
- NL82297.091.22
- Acronym
- GATE
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GATE Study: Endoscopic Sutured Gastroplasty in Type 2 Diabetic, Obese Patients
- ClinicalTrials.gov ID
- NCT05599477
- Acronym / sponsor ID
- GATE / NL82297.091.22
- Conditions
- Diabete Type 2, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Endotools Therapeutics
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic sutured gastroplasty | Experimental | Device: Endoscopic sutured gastroplasty with endomina |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 18-65 years;
- Diagnosed with DM2
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic sutured gastroplasty with endominaAlso: Endoscopic sleeve gastroplastyThe endomina is is used to perform endoscopic sutured gastroplasty. Two guidewires are introduced via an upper GI endoscopy down to the duodenum. The endomina system is introduced and the endoscope is inserted and fixed to the system. Next a needle preloaded with suture is introduced into the platform. The stomach wall is grasped with a forceps and pulled back. The needle is pushed through the wall, and a first tag is released. The needle is retracted, the first plicature is released and a second plicature is made with the same needle at the opposite wall. Then the pretied knot is grasped and tightened until both plicatures are firmly apposed. The same procedure is repeated along the great curvature from the incisura to the upper body. The procedure will include the placement of 6-9 sutures. The first suture is done at the level of the incisura, at the lower part of the greater curvature. The following stitches are placed along the body of the stomach | Device | Endoscopic sutured gastroplasty |
Primary outcome
Reduction in HbA1c
Time frame: 1 year
a reduction of HbA1C of at least 0.7%
13 secondary outcomes
Rate of Serious Adverse Events (SAE) and Serious Adverse Device Effects (SADE) during and post procedure
Time frame: 1 year
Adverse events up to 1-month follow-up for subjects undergoing the procedure under procedural sedation with propofol
Time frame: 1 year
Cardiovascular events (stroke/TIA, myocardial infarction, admission for heart failure) and all-cause mortality
Time frame: 1 year
Reduction of HbA1C at 14 days, 1 month, 3, 6, and 9 months after ESG
Time frame: 1 year
Reduction in fasting plasma glucose levels at 14 days, 1 month, 3, 6, 9 and 12 months after ESG
Time frame: 1 year
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
Time frame: 1 year
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
Time frame: 1 year
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
Time frame: 1 year
Decrease in blood pressure expressed in mmHg at 14 days, 1 month, 3, 6, 9 and 12 months after ESG
Time frame: 1 year
EQ-5D-5L at 14 days, 1 month, 3, 6 and 12 months after ESG
Time frame: 1 year
Diabetes Treatment Satisfaction Questionnaire at 14 days, 1 month, 3, 6, 9 and 12 months after ESG
Time frame: 1 year
Quality adjusted life years (QALYs)
Time frame: 1 year
Costs and cost-effectiveness.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endoscopic sutured gastroplasty with endomina in people with Diabete Type 2 and Obesity, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in HbA1c (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.