The purpose of this study is to determine whether RFVA of the duodenal mucosa with or without the combination of Semaglutide is a safe and effective treatment to remove the need for insulin therapy among patients with T2D who are on stable doses of insulin.
This is a prospective, open-label pilot, to determine safety and efficacy of step-up therapy with RFVA and Semaglutide
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
RF Vapor ablation of the duodenum
Clinica Colonial
Santiago, Chile
Safety Endpoint
Number of subjects with reported device or procedure related SAEs or UADEs.
Time frame: 1 month
Efficacy Endpoint
Percentage of patients free of insulin at 168 days post RF vapor ablation with an HbA1c ≤ 7.5% (58 mmol/mol)
Time frame: 168 days
Technical success of duodenal mucosal ablation using RFVA
The percentage of patients who underwent the procedure and received therapy to ≥ 6cm.
Time frame: 1 month
Procedure time
Procedure time of duodenal mucosal ablation, defined as the interval between catheter insertion and removal following completion of the procedure.
Time frame: 1 month
Proportion of patients who remain free of insulin and Semaglutide
\- Proportion of patients who remain free of insulin and Semaglutide at 168 days (24 weeks) following RFVA with a HbA1c ≤ 7.5% (58 mmol/mol)
Time frame: 24 weeks
Absolute change in HbA1c
Absolute change in HbA1c at 84 days post-procedure.
Time frame: 84 days
Absolute change in HbA1c by visit over time
Absolute change in HbA1c by visit over time
Time frame: 168 days
Change in fasting plasma glucose from baseline
Change in fasting plasma glucose from baseline to 84 and 168 days post-procedure.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 168 days
Change in fasting plasma glucose by visit over time
Change in fasting plasma glucose by visit over time (up to 168 days post-procedure).
Time frame: 168 days
Change in HOMA-IR by visit over time
Change in HOMA-IR by visit over time (up to 168 days post- procedure).
Time frame: 168 days
Change in alanine transaminase
Change in alanine transaminase from baseline to 168 days post-procedure.
Time frame: 168 days
Change in aspartate transaminase
Change in aspartate transaminase from baseline to 168 days post-procedure.
Time frame: 168 days
Change in fibrosis index 4 (FIB-4) score
Change in fibrosis index 4 (FIB-4) score between baseline to 84, baseline to 168 days and 84 to 168 days post-procedure.
Time frame: 168 days
Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score
Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score between baseline to 84, baseline to 168 days and 84 to 168 days post-procedure.
Time frame: 168 days
Change in BMI
Change in body mass index (BMI) between baseline to 84 and 168 days post-procedure.
Time frame: 168 days
Reduction in insulin dose from baseline
Reduction in mean and median dose of insulin from baseline to 168 days post procedure.
Time frame: 168 days
Proportion of subjects with ≥50% reduction in their insulin dose at 168 days
Proportion of subjects with ≥50% reduction in their insulin dose at 168 days post- procedure.
Time frame: 168 days
Percentage of patients who remain off insulin
Percentage of patients who remain off insulin at 168 days post-procedure.
Time frame: 168 days
Proportion of patients who can tolerate semaglutide without need for discontinuation
Proportion of patients who can tolerate semaglutide without need for discontinuation up to 168 days post-procedure.
Time frame: 168 days