Набор по приглашению NCT05551559

The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease

Без фазы С лечением Non-Alcoholic Fatty Liver Disease

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: bariatric surgery.
Кому может быть актуально: Состояния в реестре: Non-Alcoholic Fatty Liver Disease. 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: Финляндия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of this study is to investigate the mechanisms underlying bariatric surgery-induced resolution of non-alcoholic fatty liver disease.

Подробное описание

Bariatric surgery is one of the few currently available treatment options for non-alcoholic fatty liver disease (NAFLD). In most cases, NAFLD is entirely ameliorated after the surgery but in some individuals, the disease may persist or even progress. The mechanisms underlying the bariatric surgery-mediated resolution of NAFLD and the heterogeneity in the response remain poorly understood. In this study, the investigators will examine the metabolic effects of bariatric surgery-induced resolution of NAFLD. To this end, study subjects who have previously undergone bariatric surgery and metabolic studies will be invited for a follow-up visit for physical examination, evaluation of body composition with bioelectrical impedance and quantification of liver stiffness using non-invasive transient elastography and magnetic resonance elastography (MRE). Body fat composition will be evaluated by magnetic resonance imaging (MRI) and hepatic lipid content will be measured with magnetic resonance spectroscopy (MRS). In addition, 1H nuclear magnetic resonance (NMR) metabolomic analyses will be carried out from plasma samples collected both before and after bariatric surgery. Insulin resistance will be assessed using the HOMA-IR index and the genotypes in disease-modifying genes including PNPLA3, TM6SF2, MBOAT7, MARC1 and HSD17B13 will be assessed. Liver biopsies were obtained at the time of bariatric surgery and, in individuals with a clinical indication, a follow-up liver biopsy will be obtained.

Вмешательства

Процедура bariatric surgery
bariatric surgery

Первичные конечные точки

change in concentration of plasma metabolites as determined by nuclear magnetic resonance [Срок оценки: change between follow-up visit and pre-surgery visit , expected average 10 years]
change in severity of NAFLD as determined by elastography [Срок оценки: change between follow-up visit and pre-surgery visit , expected average 10 years]
change in severity of NAFLD as determined by magnetic resonance spectroscopy [Срок оценки: change between follow-up visit and pre-surgery visit , expected average 10 years]
change in severity of NAFLD as determined by liver histology [Срок оценки: change between follow-up visit and pre-surgery visit , expected average 10 years]

Критерии участия

Критерии включения

Participants must have undergone bariatric surgery and previously participated in a metabolic study in our research group.
Participants must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
Age range from 18-75 years.