Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases
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: Hyperbaric oxygen therapy.
- Кому может быть актуально
- Состояния в реестре: Metabolic Dysfunction-associated Steatotic Liver Disease, Hepatic Steatosis, Non-alcoholic Fatty Liver Diseases. Базовые параметры: 18 лет — 75 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Efficacy and Safety of Hyperbaric Oxygen Therapy in Adult Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD) Patients : a Randomized Controlled Trial
Обзор
The goal of this clinical trial is to learn if hyperbaric oxygen therapy (HBOT) works to treat Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD). The main questions it aims to answer are: Does HBOT decreases the fat content and fibrosis state of liver in adult MASLD patients? Does HBOT improves the liver function and metabolic condition in adult MASLD patients? Participants will: Receive HBOT for 20 times in 1 month or recerive regular drug; Visit the clinic for checkups and tests at the starting, ending of the therapy and 6 month after the therapy.
Подробное описание
Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD) patients who meet our principles would be randomized into 2 groups: the HBOT group and CON group. The entire project is not blinded. In HBOT group, participants will receive HBOT for 20 times in 1 month (2.0ATA, 60min), which is the common setting in clinical use.The CON group, which means the control group, recerives regular drug, like liver-protective drugs and hypoglycemic drugs. The visiting times are week 0 (starting of the project), week 4 (ending of the therapy), week 28 (6 months after the therapy), when participants get checkups and tests. The primary outcome of our study are the change of liver fat content and stiffness in Fibroscan. The secondary outcomes invovle changes of liver function enzymes and metabolism.
Вмешательства
- Процедура Hyperbaric oxygen therapy
Participants receive 20 session of hyperbaric oxygen therapy (HBOT) in one month (inhalation of 100% oxygen in a pressure chamber under 2.0 ATA for 60 minutes).
Первичные конечные точки
- Change of liver stiffness [Срок оценки: Before the 1-month treatment, directly after the treatment, 6 months after the treatment]
- Change of liver fat content [Срок оценки: Before the 1-month treatment, directly after the treatment, 6 months after the treatment]
Вторичные конечные точки (5)
- Change of liver enzymes [Срок оценки: Before the 1-month treatment, directly after the treatment, 6 months after the treatment]
- Change of fasting blood glugose [Срок оценки: Before the 1-month treatment, directly after the treatment, 6 months after the treatment]
- Change of fasting insulin [Срок оценки: Before the 1-month treatment, directly after the treatment, 6 months after the treatment]
- Change of cholesterol [Срок оценки: Before the 1-month treatment, directly after the treatment, 6 months after the treatment]
- change of total triglyceride [Срок оценки: Before the 1-month treatment, directly after the treatment, 6 months after the treatment]
Критерии участия
Критерии включения
- Metabolic dysfunction-associated steatotic liver disease patients
Критерии исключения
- Participants are unfit for hyperbaric treatment.
- Participants with prior oxygen therapy within the last 6 months.
- Participants with history of viral hepatitis, hemochromatosis, Wilson disease, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, biliary obstruction, alpha-1 antitrypsin deficiency.
- Participants with severe organ dysfunctions or malignant tumors.
- Participants have weight loss plan or major operations within the last 6 months.
- Participants are unable to provide informed consent or currently participating in or has within the last 3 months participated in any other clinical trial.
- Participants are pregnant or lactating.
- Participants with claustrophobia or that cannot decompress properly.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- General Hospital of Eastern Theater Command — Нанкин
Идентификаторы
NCT: NCT06619808 · 2024DZKY-052-01