Duodenal pulsENDO as an Early Treatment for Type 2 DM
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorChinese University of Hong Kong
About this trial
This study is designed to evaluate the efficacy and safety of endoscopic duodenal re-cellularization therapy using pulsed electric field in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Duration of T2DM </= 2 years
HbA1c </= 7.5%
On 0-1 oral diabetes medications
Disqualifiers
Previous treatment with pulsENDO or similar procedure
Previous GI surgery that could preclude the ability to perform pulsENDO, or acute gastric and duodenal pathology that increased the risk of pulsENDO
Type I DM, DM secondary to specific disease or having any history of ketoacidosis
Fasting C-peptide level <0.5ug/L
Trial design
Design model
Single group
Treatments tested in this trial
pulsENDO treatment
Procedure/SurgeryThe pulsENDO procedure utilizes the pulsENDO catheter to deliver non-thermal pulsed electric field to the duodenum to induce cell regeneration. The catheter is introduced to the duodenum through the mouth using a guide wire and the therapy is applied to treat the duodenum under endoscopic visualisation, starting from D4 and repeated proximally. Approximately 10-18 cm of axial length of the duodenum is treated.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Endoscopic duodenal recellularization via electroporation therapy (pulsENDO)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
HbA1c ≤6.5% without glucose lowering drugs
Proportion of participants with HbA1c ≤6.5% without glucose lowering drugs
Time frame
6 months post-procedureSecondary outcomes
1
HbA1c
Change in HbA1c (%) from baseline to Month 24
Time frame
24 months post-procedure2
Total body weight loss (%TBWL)
Percent total body weight loss (%TBWL) from baseline to Month 24
Time frame
24 months post-procedure3
Incidence of adverse events
Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Time frame
within 30 days post-procedure4
Body fat percentage
Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 24
Time frame
24 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov