Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05711043
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-02
First Post:
2023-01-23
Brief Title:
The GATE Trial Endoscopic Sutured Gastroplasty in Type 2 Diabetic Obese Patients Using the Endomina Device
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
The GATE Trial Endoscopic Sutured Gastroplasty in Type 2 Diabetic Obese Patients Using the Endomina Device - a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GATE
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 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 kgm² 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 ie BMI of 35 kgm² 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 SA 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 kgm² 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 parametersendpoints 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
Bariatric surgery is indicated at a body mass index BMI 35 kgm² 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 ie BMI of 35 kgm² 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 SA 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 kgm² 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 parametersendpoints 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None