Duodenal Recellularization Via Electroporation Therapy for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease (DRESS-1 Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
This study is designed to evaluate the efficacy, safety, and mechanisms of pulsENDO procedure in patients with T2DM and its effect on MASLD.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Endoscopic duodenal recellularization via electroporation therapy (pulsENDO)
pulsENDO procedure entails the ablation of the duodenal mucosa with irreversible electroporation (IRE)
干预措施: pulsENDO treatment (Procedure)
结局指标
主要结局
HbA1c
时间窗: 24 months post-procedure
Change in HbA1c (%) from baseline to Month 24
Improvement of MAFLD
时间窗: 12 months post-procedure
Proportion of subjects with improvement of liver steatosis and without worsening of fibrosis on liver histology
次要结局
- Total body weight loss (%TBWL)(24 months post-procedure)
- Incidence of adverse events(within 30 days post-procedure)
- Body fat percentage(24 months post-procedure)
- Change in Quality of Life(24 months post-procedure)
- Faecal microbiome(24 months post-procedure)
- Changes in background glucose lowering medications(24 months post-procedure)
研究者
Stephen KK Ng
Principal Investigator
Chinese University of Hong Kong