MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Syndrome (MetS), T2DM (Type 2 Diabetes Mellitus)
Conditions
Brief summary
This study is designed to evaluate the efficacy, safety, and mechanisms of pulsENDO procedure in patients with T2DM and its effect on MASLD.
Detailed description
This is a prospective, single-arm feasibility study enrolling individuals with type 2 diabetes mellitus (T2DM) who have failed to achieve adequate glycemic control with oral glucose-lowering medications. Participants will undergo the pulsENDO procedure and liver biopsies both prior to and after the procedure to evaluate its effects on metabolically associated fatty liver disease (MAFLD). They will be followed for 12 months to assess the primary endpoint and for a total of 2 years. Participants are permitted to undergo a repeat pulsENDO procedure once if they initially respond but experience a recurrence of suboptimal diabetes management between 1 and 2 years after the procedure. They will be followed up for an additional year after the repeated procedure.
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 70 Years
Healthy volunteers
No
Inclusion criteria
* Duration of T2DM \< 10 years * BMI 18.5-40kg/m2 * Failure to achieve adequate HbA1c reduction (7.5 - 11%) after at least 3 months stable dosage of oral glucose lowering drugs
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 1 DM, DM secondary to specific disease or having any history of ketoacidosis * Patients on insulin * 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 * Patients with cirrhosis due to causes other than MASLD * 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 | 24 months post-procedure | Change in HbA1c (%) from baseline to Month 24 |
| Improvement of MAFLD | 12 months post-procedure | Proportion of subjects with improvement of liver steatosis and without worsening of fibrosis on liver histology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Faecal microbiome | 24 months post-procedure | changes in faecal microbiome from baseline to Month 24 |
| Changes in background glucose lowering medications | 24 months post-procedure | Changes in glucose lowering medications from baseline to Month 24 |
Countries
Hong Kong
Contacts
CONTACTStephen Ng, FRCSEd(Gen)
CONTACTJenny Study coordinator
PRINCIPAL_INVESTIGATORStephen Ng, FRCSEd(Gen)
Prince of Wales Hospital, the Chinese University of Hong Kong
Outcome results
None listed