Endoscopic application of pulsed electric fields by the Endogenex system® for duodenal Mucosal regeneration for elimination of INsulin in the treatmENT of type 2 diabetes: a first in human safety, feasibility and efficacy study

Recruiting

Conditions: diabetes
diabetes mellitus type 2
10018424

Registration Number: NL-OMON54013

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 14

Inclusion Criteria

1. Diagnosed with Type 2 Diabetes
2. 28 -75 years of age
3. Treatment with long acting insulin <= 10 years
4. On daily long acting insulin dose <= 1 U/kg
5. BMI >= 24 and <= 40 kg/m2
6. HbA1c <= 8.0% (64 mmol/mol)
7. Fasting C-peptide >= 0.2 nmol/L (0.6 ng/ml)
8. Willing to comply with study requirements and able to understand and comply
with informed consent
9. Signed informed consent form

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 use of GLP-1 analogue.
4. A positive Anti-GAD test, as an indication of type 1 diabetes mellitus or
Latent Autoimmune Diabetes of the Adult (LADA) with progressive beta-cell loss.
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Safety: Incidence rate of adverse events.<br>• Feasibility: Procedure time and technical success rate<br>• Primary efficacy: Protocol driven free of insulin at 6 months and HbA1c <= 7.5<br>%.</p>

Secondary Outcome Measures

Name	Time	Method
<p>• Secondary efficacy:<br>- Time in range (continuous glucose monitoring),<br>- liver fat fraction (MRI-PDFF)<br>- sympathovagal activity (Nexfin device).<br>- blood HbA1c, HOMA-IR, Fasting Plasma Glucose<br>- Weight, BMI, waist circumference<br>- lipid panel, liverenzymes etc.<br>- micro albumin</p>