diabetes diabetes mellitus type 2
Conditions
Interventions
A single PEF-DMR procedure, in combination with GLP-1RA to discontinue insulin
therapy.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with Type 2 Diabetes 2. 28 -75 years of age 3. Treatment with long acting insulin = 24 and = 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Safety: Incidence rate of adverse events. • Feasibility: Procedure time and technical success rate • Primary efficacy: Protocol driven free of insulin at 6 months and HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| • Secondary efficacy: - Time in range (continuous glucose monitoring), - liver fat fraction (MRI-PDFF) - sympathovagal activity (Nexfin device). - blood HbA1c, HOMA-IR, Fasting Plasma Glucose - Weight, BMI, waist circumference - lipid panel, liverenzymes etc. - micro albumin | — |
Countries
Netherlands
Outcome results
None listed