Diabetes Mellitus Type 2 in ObeseGATENCT05711043
The GATE Trial: Endoscopic Sutured Gastroplasty in Type 2 Diabetic, Obese Patients Using the Endomina Device
A study testing Endoscopic sutured gastroplasty with endomina in people with Diabetes Mellitus Type 2 in Obese, run by Radboud University Medical Center at 1 site in Netherlands.
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
- Diabetes Mellitus Type 2 in Obese
- 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
- 58 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2023to 1 Mar 2025
- Phase
- Interventional
- 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
- currently under stable dose of insulin for at least 6 months
- with or without use of any other oral glucose lowering medication (e.g., metformin, glucagon-like peptide (GLP)-1 receptor agonist)
- HbA1c level of 7.0-11.0% (53-75 mmol/mol) prior to inclusion
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- BMI of 30-40 kg/m²
- 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
- Gastrointestinal 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 14Show 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)
- Known with, or history of, eating disorder
- Pregnancy, breast feeding or desire to become pregnant in the coming 12 months
- Any previous bariatric surgery, or endoscopic obesity-related intervention (including Primary Obesity Surgery Endoscopic (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 another study (involving change of treatment).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Rijnstate
Arnhem
Fenna Beeren, fenna.beeren@radboudumc.nl
About this study
Official title: The GATE Trial: Endoscopic Sutured Gastroplasty in Type 2 Diabetic, Obese Patients Using the Endomina Device - a Randomized Controlled Trial
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. Interventions for weight loss in patients with DM2 include diet, exercise, but also pharmacotherapy and bariatric surgery.
Bariatric surgery is indicated at a body mass index (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 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 sutured gastroplasty (ESG), performed with the endomina device (EndoTools Therapeutics S.A.). There is however a paucity of data showing the effect of ESG on metabolic comorbidities including DM2. We hypothesize that ESG with the endomina device will improve glycemic control in patients with DM2 and obesity.
Read more
Objective: To evaluate the efficacy of ESG with the endomina device on glycemic control, in obese insulin treated type 2 diabetic patients.
Study design: This is a prospective, randomized controlled trial. Study population: 58 subjects (29 in each group) with a BMI between 30 and 40 kg/m² and DM2, treated with insulin therapy.
Intervention (if applicable): The intervention group will receive ESG performed with the endomina device. The control group will receive standard diabetic care.
Main study parameters/endpoints: The primary endpoint is the proportion of patients with a clinically relevant reduction of insulin dose. Secondary endpoints include among others reduction in HbA1c, remission of diabetes, weight loss, quality of life and (serious) adverse events.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: An ESG with the endomina device is known to have only minor adverse events (transient abdominal cramps, nausea, vomiting), and a serious adverse event rate of <1% (no surgical intervention needed, no mortality).
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Being tested
- Endoscopic sutured gastroplasty with endomina
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 ESG, Endoscopic sleeve gastrectomy, Endomina
Subjects in the intervention group will be treated with an ESG with the endomina ® and TAPES devices (Endo Tools Therapeutics S.A.), both CE-marked for endoscopic gastroplasty. The endomina is a device that can be attached to an endoscope and allows remote actuation of the device during a peroral intervention. Thanks to a therapeutic channel that can be angled perpendicularly to the axis of vision of the endoscope, it allows the possibilities of making transoral full thickness tissue apposition and performing, via a transoral route, large plications with tight serosa to serosa apposition in the stomach. This suturing will be done from the incisura to the upper body of the stomach, along the great curvature with TAPES, a single use needle preloaded with suture.
In addition to the endomina device, any other required endoscopic accessories can be used during the procedure (e.g., grasping forceps, loop cutter).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Endoscopic sutured gastroplasty with endomina device Receives: Device: Endoscopic sutured gastroplasty with endomina |
| Control group | No intervention | Standard diabetes care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with a clinically relevant reduction of insulin dose after 12 months
A clinically relevant reduction is defined as a 50% dose reduction.
Measured: 12 months
Secondary outcomes (19)
Rate of Serious Adverse Events (SAE) and Serious Adverse Device Effects (SADE) during and post procedure at 12 months
Measured: 1 year
(Serious) adverse events up to 1-month follow-up for subjects undergoing the procedure under procedural sedation with propofol
Measured: 1 month
Cardiovascular events (stroke/Transient Ischemic Attack (TIA), myocardial infarction, admission for heart failure) after 12 months
Measured: 1 year
All-cause mortality after 12 months
Measured: 1 year
Reduction in HbA1c after 1 month, 3-, 6-, and 12-months follow-up
Measured: 1 year
Proportion of subjects with a clinically relevant reduction of insulin dose after 1 month, 3 and 6 months.
Measured: 6 months
Proportion of subjects with a clinically relevant decrease in HbA1c after 1 month, 3-, 6-, and 12-months follow-up. A clinically relevant decrease in HbA1c is defined as 2.6% (5mmol/mol).
Measured: 1 year
Reduction in fasting plasma glucose levels after 1 month, 3-, 6-, and 12-months follow-up.
Measured: 1 year
Proportion of subjects with reduced number and/or reduced dose(s) of (oral) glucose lowering medication after 1 month, 3-, 6-, and 12-months follow-up.
Measured: 1 year
Proportion of subjects with remission of diabetes after 6, 9 and 12 months. Remission is defined as HbA1c < 6.5% (48 mmol/mol), fasting glucose of < 5.6 mmol/l without glucose-lowering medication for at least 3 months.
Measured: 1 year
Proportion of subjects with mean % excess weight loss (%EWL) of more than 25% after 1 month, 3-, 6-, and 12-months follow-up.
Measured: 1 year
%EWL after 1 month, 3-, 6-, and 12-months follow-up.
Measured: 1 year
Proportion of subjects with mean % total body weight loss (%TBWL) of more than 5% after 1 month, 3-, 6-, and 12-months follow-up.
Measured: 1 year
%TBWL after 1 month, 3-, 6-, and 12-months follow-up.
Measured: 1 year
Decrease in blood pressure after 1 month, 3-, 6-, and 12-months follow-up.
Measured: 1 year
EuroQol 5Dimension 5Level (EQ-5D-5L) after 1 month, 3-, 6-, and 12-months follow-up.
Measured: 1 year
Diabetes Treatment Satisfaction Questionnaire (DTSQ) after 1 month, 3-, 6-, and 12-months follow-up.
Measured: 1 year
Costs
Costs include health care recourses used (including intervention, endomina device and TAPES, hospital admissions, visits to specialists and general practitioner, emergency room visits, medications used), costs for insulin therapy (including medication, administration, glycemia measurement material)
Measured: 1 year
Cost-effectiveness
Using quality adjusted life years (QALYs)
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 posted2 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 in ObeseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fenna Beeren, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711043
- Sponsor's protocol ID
- NL83606.091.23
- Acronym
- GATE
- Status last verified
- Feb 2023
- First submitted
- 23 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request after publication
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GATE Trial: Endoscopic Sutured Gastroplasty in Type 2 Diabetic, Obese Patients Using the Endomina Device - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05711043
- Acronym / sponsor ID
- GATE / NL83606.091.23
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 2 Feb 2023 (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. Interventions for weight loss in patients with DM2 include diet, exercise, but also pharmacotherapy and bariatric surgery.
Bariatric surgery is indicated at a body mass index (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 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 sutured gastroplasty (ESG), performed with the endomina device (EndoTools Therapeutics S.A.). There is however a paucity of data showing the effect of ESG on metabolic comorbidities including DM2. We hypothesize that ESG with the endomina device will improve glycemic control in patients with DM2 and obesity.
Objective: To evaluate the efficacy of ESG with the endomina device on glycemic control, in obese insulin treated type 2 diabetic patients.
Study design: This is a prospective, randomized controlled trial. Study population: 58 subjects (29 in each group) with a BMI between 30 and 40 kg/m² and DM2, treated with insulin therapy.
Intervention (if applicable): The intervention group will receive ESG performed with the endomina device. The control group will receive standard diabetic care.
Main study parameters/endpoints: The primary endpoint is the proportion of patients with a clinically relevant reduction of insulin dose. Secondary endpoints include among others reduction in HbA1c, remission of diabetes, weight loss, quality of life and (serious) adverse events.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: An ESG with the endomina device is known to have only minor adverse events (transient abdominal cramps, nausea, vomiting), and a serious adverse event rate of <1% (no surgical intervention needed, no mortality).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Endoscopic sutured gastroplasty with endominaEndoscopic sutured gastroplasty with endomina device |
| Control group | No intervention | –Standard diabetes care |
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
- 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 (14 listed)
- Achalasia and any other esophageal motility disorders
- Severe esophagitis (grade C or D)
- Gastro-duodenal ulcer
- Gastrointestinal 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: ESG, Endoscopic sleeve gastrectomy, EndominaSubjects in the intervention group will be treated with an ESG with the endomina ® and TAPES devices (Endo Tools Therapeutics S.A.), both CE-marked for endoscopic gastroplasty. The endomina is a device that can be attached to an endoscope and allows remote actuation of the device during a peroral intervention. Thanks to a therapeutic channel that can be angled perpendicularly to the axis of vision of the endoscope, it allows the possibilities of making transoral full thickness tissue apposition and performing, via a transoral route, large plications with tight serosa to serosa apposition in the stomach. This suturing will be done from the incisura to the upper body of the stomach, along the great curvature with TAPES, a single use needle preloaded with suture. In addition to the endomina device, any other required endoscopic accessories can be used during the procedure (e.g., grasping forceps, loop cutter). | Device | Intervention group |
Primary outcome
Proportion of subjects with a clinically relevant reduction of insulin dose after 12 months
Time frame: 12 months
A clinically relevant reduction is defined as a 50% dose reduction.
19 secondary outcomes
Rate of Serious Adverse Events (SAE) and Serious Adverse Device Effects (SADE) during and post procedure at 12 months
Time frame: 1 year
(Serious) adverse events up to 1-month follow-up for subjects undergoing the procedure under procedural sedation with propofol
Time frame: 1 month
Cardiovascular events (stroke/Transient Ischemic Attack (TIA), myocardial infarction, admission for heart failure) after 12 months
Time frame: 1 year
All-cause mortality after 12 months
Time frame: 1 year
Reduction in HbA1c after 1 month, 3-, 6-, and 12-months follow-up
Time frame: 1 year
Proportion of subjects with a clinically relevant reduction of insulin dose after 1 month, 3 and 6 months.
Time frame: 6 months
Proportion of subjects with a clinically relevant decrease in HbA1c after 1 month, 3-, 6-, and 12-months follow-up. A clinically relevant decrease in HbA1c is defined as 2.6% (5mmol/mol).
Time frame: 1 year
Reduction in fasting plasma glucose levels after 1 month, 3-, 6-, and 12-months follow-up.
Time frame: 1 year
Proportion of subjects with reduced number and/or reduced dose(s) of (oral) glucose lowering medication after 1 month, 3-, 6-, and 12-months follow-up.
Time frame: 1 year
Proportion of subjects with remission of diabetes after 6, 9 and 12 months. Remission is defined as HbA1c < 6.5% (48 mmol/mol), fasting glucose of < 5.6 mmol/l without glucose-lowering medication for at least 3 months.
Time frame: 1 year
Proportion of subjects with mean % excess weight loss (%EWL) of more than 25% after 1 month, 3-, 6-, and 12-months follow-up.
Time frame: 1 year
%EWL after 1 month, 3-, 6-, and 12-months follow-up.
Time frame: 1 year
Proportion of subjects with mean % total body weight loss (%TBWL) of more than 5% after 1 month, 3-, 6-, and 12-months follow-up.
Time frame: 1 year
%TBWL after 1 month, 3-, 6-, and 12-months follow-up.
Time frame: 1 year
Decrease in blood pressure after 1 month, 3-, 6-, and 12-months follow-up.
Time frame: 1 year
EuroQol 5Dimension 5Level (EQ-5D-5L) after 1 month, 3-, 6-, and 12-months follow-up.
Time frame: 1 year
Diabetes Treatment Satisfaction Questionnaire (DTSQ) after 1 month, 3-, 6-, and 12-months follow-up.
Time frame: 1 year
Costs
Time frame: 1 year
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 2 Feb 2023.
- Individual participant dataSharing planned: Yes. Upon request after publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic sutured gastroplasty with endomina in people with Diabetes Mellitus Type 2 in Obese, run by Radboud University Medical Center at 1 site in Netherlands.
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 14 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 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with a clinically relevant reduction of insulin dose after 12 months (time frame: 12 months). 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 2 Feb 2023.