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Набор скоро начнётся NCT06764056

Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)

Без фазы С лечением Metabolic Associated Fatty Liver Disease Metabolic Associated-dysfunction Steatohepatitis (MASH) Obesity

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: semaglutide, Diet.
Кому может быть актуально
Состояния в реестре: Metabolic Associated Fatty Liver Disease, Metabolic Associated-dysfunction Steatohepatitis (MASH), Obesity. Базовые параметры: от 18 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
Канада
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

Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Through an Individualized Nutritionnal Approach and Semaglutide Therapy.

Обзор

The goal of this clinical trial is to improve the treatment of hepatic steatosis associated with obesity with pharmacological and nutritionnal approaches. The main question it aims to answer is: Does an individualized nutritionnal approach with a dietician combined with medication targeting obesity is the most efficient way to treat hepatic steatosis associated with obesity? Participants will either participate in one of three groups: * Nutrition: Participant will only have a regular follow-up with a registered dietician; * Nutrition + Semaglutide: Participants will start a new medication targeting obesity and will have a regular follow-up with a registered dietician; * Semaglutide: Participants will start a new medication targeting obesity.

Подробное описание

Participants in each group will be followed during a year for 4 timepoints (0, 3, 6 and 12 months). Blood and feces samples, anthropometric measures, transient elastography measurements and health questionnaires will be assessed at each timepoint.

The nutritionnal intervention targeting hepatic steastosis associated with obesity will use conclusions from a systematic review we conducted on nutritionnal approaches to treat liver steatosis.

Вмешательства

  • Препарат semaglutide
    Participants receiving this intervention will be starting with a dose of semaglutide 0.25 mg. Physicians will follow Wegovy® Dosing Schedule guidelines, ending with a final dose of 2.4 mg at the fifth month. Type 2 diabetes participants wishing to stop at 1.0 mg will be allowed.
  • Другое Diet
    Participants receiving this intervention will be seeing a registered dietician at each visit. The individualized approach will be based on recent literature (mostly hypocaloric) by using different methods.

Первичные конечные точки

  • Liver Steatosis [Срок оценки: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
  • Liver Stiffness [Срок оценки: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
Вторичные конечные точки (11)
  • Liver function (biochemistry) [Срок оценки: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
  • Lipid panel [Срок оценки: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
  • Change from Baseline in the gut microbiota diversity [Срок оценки: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
  • Change from Baseline in blood lipids and metabolites [Срок оценки: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
  • Glucose [Срок оценки: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
  • Insulin [Срок оценки: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
  • Glycated hemoglobin [Срок оценки: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
  • C-reactive protein [Срок оценки: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
  • Liver enzymes [Срок оценки: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
  • Fatty liver index (FLI) [Срок оценки: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
  • Fibrosis-4 index (FIB-4) [Срок оценки: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]

Критерии участия

Критерии включения

  • Body mass index between 30 and 50 kg/m2;
  • Stade 2 or 3 (S2 or S3) hepatic steatosis with or without liver fibrosis.

Критерии исключения

  • Type 1 diabetes diagnosis;
  • Alcohol consumption exceeding recommendations \[>140 g/week (women) and >210 g/week (men)\];
  • Known chronic hepatic disease non-steatotic at the entry of the study (Wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency, viral hepatitis, auto-immune hepatitis, etc.);
  • Pharmacological treatment targeting obesity active or ended in the last 3 months;
  • Bariatric surgery;
  • Gastro-intestinal pathologies (GI cancers, IBD, etc.);
  • Capsulated probiotics consumption;
  • Antibiotic treatment in the last 3 months;
  • Pregnancy;
  • Cirrhosis diagnosis (hepatic decompensation).

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

Канада · 1 центр
  • Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec — Québec

Идентификаторы

NCT: NCT06764056 · 2025-4271

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗