Меню
Набор скоро начнётся NCT07390422

Duodenal pulsENDO for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease

Без фазы С лечением T2DM (Type 2 Diabetes Mellitus) MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Metabolic Syndrome (MetS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: pulsENDO treatment.
Кому может быть актуально
Состояния в реестре: T2DM (Type 2 Diabetes Mellitus), MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Syndrome (MetS). Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Duodenal Recellularization Via Electroporation Therapy for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease (DRESS-1 Study)

Обзор

This study is designed to evaluate the efficacy, safety, and mechanisms of pulsENDO procedure in patients with T2DM and its effect on MASLD.

Подробное описание

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 ReCET 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.

Вмешательства

  • Процедура pulsENDO 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.

Первичные конечные точки

  • HbA1c [Срок оценки: 24 months post-procedure]
  • Improvement of MAFLD [Срок оценки: 12 months post-procedure]
Вторичные конечные точки (6)
  • Total body weight loss (%TBWL) [Срок оценки: 24 months post-procedure]
  • Incidence of adverse events [Срок оценки: within 30 days post-procedure]
  • Body fat percentage [Срок оценки: 24 months post-procedure]
  • Change in Quality of Life [Срок оценки: 24 months post-procedure]
  • Faecal microbiome [Срок оценки: 24 months post-procedure]
  • Changes in background glucose lowering medications [Срок оценки: 24 months post-procedure]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • Chinese University of Hong Kong — Shatin

Идентификаторы

NCT: NCT07390422 · CRE-2025.876

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗