Diabete Mellitus, T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
Conditions
Brief summary
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).
Detailed description
This is a prospective, single-armed, feasibility study enrolling individuals with a recent diagnosis of type 2 diabetes. Participants will be followed for 6 months for the primary endpoint and 2 years in total.
Interventions
PROCEDUREpulsENDO treatment
The 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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Duration of T2DM \</= 2 years * HbA1c \</= 7.5% * On 0-1 oral diabetes medications
Exclusion criteria
* 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 * Any inflammatory disease of the gastrointestinal tract such as Crohn's disease * Abnormal pathologies or conditions of the gastrointestinal tract, including duodenal polyps, ulcers or upper gastrointestinal bleeding conditions within 3 months of study * Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter or known coagulopathy * Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to study and/or there is a need or expected need to use during the study period * Currently taking medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics) * Patients who have used non-steroidal analgesics and anti-inflammatory drugs (NSAID) and corticosteroids in the past 1 month * Underlying uncontrolled endocrine problem that leads to obesity, including and not limited to hypothyroidism, Cushing syndrome and eating disorder. * Patients with contra-indications to endoscopy * Malignancy * Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma) * Pregnant or breast feeding * ASA grade IV \& V * Mental or psychiatric disorder; Drug or alcohol addiction * Other cases deemed by the examining physician as unsuitable for safe treatment * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c ≤6.5% without glucose lowering drugs | 6 months post-procedure | Proportion of participants with HbA1c ≤6.5% without glucose lowering drugs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 24 months post-procedure | Change in HbA1c (%) from baseline to Month 24 |
| Total body weight loss (%TBWL) | 24 months post-procedure | Percent total body weight loss (%TBWL) from baseline to Month 24 |
| Incidence of adverse events | within 30 days post-procedure | Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) |
| Body fat percentage | 24 months post-procedure | Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 24 |
| Change in Quality of Life | 24 months post-procedure | measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best) from baseline to Month 24 |
| Hepatic steatosis index | 24 months post-procedure | level from baseline to Month 24 |
Countries
Hong Kong
Contacts
CONTACTStephen Ng, FRCSEd(Gen)
PRINCIPAL_INVESTIGATORStephen Ng, FRCSEd(Gen)
Prince of Wales Hospital, the Chinese University of Hong Kong
Outcome results
None listed