Evaluating a new procedure for treating type 2 diabetes

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

This study is testing a new procedure that uses electric fields to help improve blood sugar control in people with insulin-dependent type 2 diabetes, along with a medication, to see if it can reduce the need for insulin.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 28 Years to 75 Years
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other)
• Locations: 1 site (Amsterdam, North-Holland)
• Trial ID: NCT05984238 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, feasibility, and efficacy of the ReCET procedure, which uses pulsed electric fields to regenerate the duodenal mucosa, in combination with the GLP-1 receptor agonist Semaglutide, for patients with insulin-dependent type 2 diabetes. Participants will be randomly assigned to receive either the ReCET treatment or a sham procedure, with the goal of achieving better glucose regulation without the need for insulin therapy. The study will also evaluate secondary outcomes related to cardiovascular, hepatic, and metabolic health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 28 to 75 with insulin-dependent type 2 diabetes and stable insulin doses.

Not a fit: Patients with type 1 diabetes or those using multiple daily doses of insulin may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with type 2 diabetes, potentially reducing their dependence on insulin.

How similar studies have performed: While this approach is innovative, similar studies exploring duodenal interventions for diabetes have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed with type 2 diabetes mellitus
2. 28 - 75 years of age
3. On daily long acting insulin dose ≤ 1 U/kg, with a stable dose (within 10%) over 1 month
4. BMI ≥ 24 and ≤ 42 kg/m2
5. HbA1c ≤ 64 mmol/mol (8.0%)
6. Fasting C-peptide ≥ 0.2 nmol/L (0.6 ng/ml)
7. Willing to comply with study requirements and able to understand and comply with signed informed consent

Exclusion Criteria:

1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
2. Current use of multiple daily doses insulin or insulin pump.
3. Current or within the last 3 months use of a GLP-1 analogue.
4. Known autoimmune disease, as evidenced by a positive Anti-GAD test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
5. Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
6. History of chronic or acute pancreatitis
7. Known active hepatitis or active liver disease
8. Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease
9. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
10. Use of anticoagulation therapy (such as phenprocoumon and acenocoumarol) which cannot be discontinued for 3-5 days before and 48 hours after the procedure and novel oral anticoagulants (such as rivaroxaban, apixaban, edoxaban and dabigatran) which cannot be discontinued for 48 hours before and 48 hours after the procedure in accordance with the local protocol
11. Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 5 days before and 48 hours after the procedure in accordance with the local protocol. Use of aspirin is allowed.
12. Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
13. Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
14. Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
15. Anemia, defined as Hgb \< 6.2 mmol/l
16. Known history of severe permanent cardiac arrhythmia's with clinical symptoms
17. Significant cardiovascular disease, including known history of valvular disease or myocardial infarction, heart failure, transient ischemic attack, or stroke within 6 months prior to the screening visit
18. With any implanted electronic devices or duodenal metallic implants
19. eGFR or MDRD \< 30 ml/min/1.73m\^2
20. Active systemic infection
21. Active malignancy within the last 5 years
22. Not potential candidates for surgery or general anesthesia
23. Active illicit substance abuse or alcoholism
24. Pregnancy or wish getting pregnant in next year
25. Participating in another ongoing clinical trial of an investigational drug or device that can interfere with the current study.
26. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation

Where this trial is running

Amsterdam, North-Holland

• Amsterdam UMC — Amsterdam, North-Holland, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Jacques JG Bergman, MD — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Study coordinator: Celine BE Busch, MD

Conditions: Diabetes Mellitus, Type 2, Type 2 Diabetes, Duodenal ablation, Endoscopy, Electroporation