BridgeMD
Compares treatment options for Diabetes Mellitus, Type 2
Official title Endoscopic Sutured Gastroplasty with Endomina® Device Versus Standard of Care in Patients with Type 2 Diabetes and Class I Obesity: a Multi-center, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05516576
What this study is testing
- What it's testing
- The primary objective of this study is to assess the efficacy of endoscopic gastric reduction with the endomina® device, in combination with standard of care, compared to standard of care alone, on the remission of diabetes 24 months after surgery, in patients with type-2 diabetes and class I obesity.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age between 18-65 years;
- Recently diagnosed Type 2 Diabetes (\<= 10 years):
- HbA1c \< 9%:
- Under non-insulin anti-diabetic treatment, i.e., metformin, sulfonylurea, glinide, DPP4i, GLP1-RA, SGLT2i, alone or in combination
- Anti-diabetic therapy stable during the last 3 months before inclusion
You likely can't join if
- Contra-indication to the use of endomina® and TAPES according to their Instruction for Use (IFU).
- Type I diabetes characterized by C peptide \<0.2 nmol/l or presence of anti-GAD, anti IA2, anti-ZNT8
- Unstable diabetic retinopathy
- Severe kidney (stage 4-5), hepatic (child B and C cirrhosis), pulmonary disease or cancer (cancer in the past 5 years);
- Short-term prognosis due to a proven serious comorbidity including severe macrovascular complications and / or a limited life expectancy (\<5 years)
- Contra-indication to endoscopic gastroplasty (...)
See the full eligibility criteria
- Age between 18-65 years;
- Recently diagnosed Type 2 Diabetes (\<= 10 years):
- HbA1c \< 9%:
- Under non-insulin anti-diabetic treatment, i.e., metformin, sulfonylurea, glinide, DPP4i, GLP1-RA, SGLT2i, alone or in combination
- Anti-diabetic therapy stable during the last 3 months before inclusion
- BMI between 30-34.9 kg/m² with adaptation for Asian population 27.5-32.5kg/m²
- Must be able to comply with all study requirements for the duration of the study as outlined in the protocol (including compliance to randomization treatment, dietary follow up, visits schedule and all study specific...
- Must be able to understand and be willing to provide written informed consent.
- Contra-indication to the use of endomina® and TAPES according to their Instruction for Use (IFU).
- Type I diabetes characterized by C peptide \<0.2 nmol/l or presence of anti-GAD, anti IA2, anti-ZNT8
- Unstable diabetic retinopathy
- Severe kidney (stage 4-5), hepatic (child B and C cirrhosis), pulmonary disease or cancer (cancer in the past 5 years);
- Short-term prognosis due to a proven serious comorbidity including severe macrovascular complications and / or a limited life expectancy (\<5 years)
- Contra-indication to endoscopic gastroplasty (...)
- Impending gastric surgery 60 days post intervention;
- Participant involved in another treatment clinical study
- Patients having alcoholic or drug addiction;
- Patients having a severe mental illness such as psychosis, bipolar disorders, severe, current depression or eating disorder such as bulimia nervosa or binge eating disorder;
- Person deprived of liberty by judicial order
- Person under guardianship or curatorship
The study team makes the final eligibility decision.
Where it's taking place
- La Tronche, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Tronche, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.