Endoscopic Application of Pulsed Electric Fields Using by the Endogenex Generation 2 ReCET System for Duodenal Mucosal Regeneration for EliMination of INsulin in the treatmENT of Type 2 Diabetes: a Randomized Double-blind Sham Controlled Trial to Evaluate Safety, Feasibility and Efficacy Study
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed electric field induced duodenal mucosal regeneration (ReCET system by the Endogenex with the Gen-2 catheter) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects with insulin-dependent type 2 diabetes mellitus.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 28
Maximum Age: 75
Healthy Volunteers: f
View:
• Diagnosed with type 2 diabetes mellitus
• 28 - 75 years of age
• On daily long acting insulin dose ≤ 1 U/kg, with a stable dose (within 10%) over 1 month
• BMI ≥ 24 and ≤ 42 kg/m2
• HbA1c ≤ 64 mmol/mol (8.0%)
• Fasting C-peptide ≥ 0.2 nmol/L (0.6 ng/ml)
• Willing to comply with study requirements and able to understand and comply with signed informed consent
Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Contact Information
Primary
Celine BE Busch, MD
c.b.busch@amsterdamumc.nl
+31621357593
Backup
Kim van den Hoek, MD
k.vandenhoek@amsterdamumc.nl
+31621357593
Time Frame
Start Date: 2023-08-03
Estimated Completion Date: 2025-10
Participants
Target number of participants: 32
Treatments
Active_comparator: ReCET procedure
Patients receive ReCET (Re-Cellularization via Electroporation Therapy), which is performed using the ReCET device.~After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started.
Sham_comparator: Sham procedure
Patients receive sham procedure, this consists of placing an Endogenex catheter, or a catheter with a similar circumference at the endoscopists discretion in the stomach and leaving it in place for 30 minutes.~After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started
Related Therapeutic Areas
Sponsors
Collaborators: Endogenex
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)