Type 2 diabetes Type 2 diabetes
Conditions
Interventions
The Revita® System is an endoscopic treatment consisting of a single catheter and console designed to lift the duodenal mucosa with saline followed by controlled circumferential hydrothermal ablation
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with Type 2 Diabetes. 2. Age >= 18 to <= 75 years. 3. Insulin naïve patients who are on stable dose (maximally approved or tolerated dose) of 2 or more glucose lowering drugs, including metformin, SU, SGLT-2i, GLP-1RA or DPP-4i and/or, TZD for at least 12 weeks. 4. BMI >= 24 and <= 40 kg/m2 5. HbA1c of >= 54 mmol/mol (7.1%) and <= 86 mmol/mol (10.0%). 6. Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis 2. Subject that use insulin 3. 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. 4. Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Bilroth2, Roux-en-Y gastric bypass, or other similar procedures 5. History of chronic or acute pancreatitis 6. Known active hepatitis or active liver disease 7. Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseasesincluding Crohn*s Disease and Celiac Disease 8. Use of anticoagulation therapy (such as warfarin, coumadin, novel oral anticoagulants [NOAC]) or anti-platelet agents (such as thienopyridine) which cannot be discontinued for 5-7 days or 2 drug half-lives before the procedure or stopped according to local portocol. Acetylsalicylic acid does not need to be discontinued.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoint is evaluated between baseline and 12 weeks post DMR and 12 weeks post retreatment with DMR. - Number (Percentage) of Patients experienced device and procedure-related SAEs, UADEs, SADEs, SUSARs Feasibility endpoint is evaluated during and after the procedure. - Number of ablations, whether a DMR was successful (>3 ablations) - Procedure time, defined as time between catheter in and catheter out. Efficacy is evaluated at 12 weeks compared to baseline and sham. - Change in HbA1c. - Mean change in Fasting Glucose/FGM | — |
Secondary
| Measure | Time frame |
|---|---|
| Are evaluated during follow-up and compared to baseline and sham at week 12 and compared to baseline and 12 weeks after (re)-DMR for patients (retreatment is optional for sham-arm). Safety - Incidences and event rates of hypoglycemic events Efficacy - Mean change in HbA1c - Mean Change in Fasting Glucose and Flash glucose monitoring (via FreeStyle Libre) - In patients with baseline abnormal ALT, AST and GGT values, change in ALT, AST, GGT - Change in body weight - Change in Fasting C-peptide - Change in FPG - Change in HOMA-IR - Change in Framingham Risk Score-Cardiovascular risk score (FRS-CVD) - Change in PDFF-MRI - Achievement of HbA1c < 53 mmol/mol (7.0%) Mechanistic - Change in resection tissue findings (morphological features, functional and cellular level changes) at 12 weeks - Mean Changes in metabolomics - Change in Plasma Citrulline - Change in Cystatin Value | — |
Countries
Netherlands
Contacts
Public ContactJJGHM Bergman
Amsterdam UMC
Outcome results
None listed