Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Through an Individualized Nutritionnal Approach and Semaglutide Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Liver Steatosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index between 30 and 50 kg/m2;
- •Stade 2 or 3 (S2 or S3) hepatic steatosis with or without liver fibrosis.
排除标准
- •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).
研究组 & 干预措施
Nutrition
This arm will only participate in an individualized nutritionnal approach.
干预措施: Diet (Other)
Nutrition + Semaglutide
This arm will initiate a pharmacological intervention to treat obesity (Semaglutide) and will participate in an individualized nutritionnal approach.
干预措施: semaglutide (Drug)
Nutrition + Semaglutide
This arm will initiate a pharmacological intervention to treat obesity (Semaglutide) and will participate in an individualized nutritionnal approach.
干预措施: Diet (Other)
Semaglutide
This arm will only initiate a pharmacological intervention to treat obesity (Semaglutide)
干预措施: semaglutide (Drug)
结局指标
主要结局
Liver Steatosis
时间窗: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Transient elastography is an ultrasound-based modality that is non-invasive and measures the degree of steatosis with the controlled attenuation parameter (CAP; dB/m) and liver stiffness (kPa).This method will be used at each visit to follow the progression and the efficiency of the interventions. The following ranges will be use to classify hepatic steatosis based on CAP (dB/m) (specific to FibroScan®): S0 (\< 302), S1 (302-331), S2 (331-337) and S3 (\>337).
Liver Stiffness
时间窗: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Transient elastography is an ultrasound-based modality that is non-invasive and measures the degree of steatosis with the controlled attenuation parameter (CAP; dB/m) and liver stiffness (kPa).This method will be used at each visit to follow the progression and the efficiency of the interventions. The following ranges will be use to classify hepatic fibrosis based on liver stiffness (kPa) (specific to FibroScan®): F0-F1 (\< 8.0), F2 (8.9-9.7), F3 (9.7-13.6) and F4 (\>13.6).
次要结局
- Liver function (biochemistry)(From enrollment to the end of the clinical trial at 12 months (for 4 visits))
- Lipid panel(From enrollment to the end of the clinical trial at 12 months (for 4 visits))
- Change from Baseline in the gut microbiota diversity(From enrollment to the end of the clinical trial at 12 months (for 4 visits))
- Change from Baseline in blood lipids and metabolites(From enrollment to the end of the clinical trial at 12 months (for 4 visits))
- Glucose(From enrollment to the end of the clinical trial at 12 months (for 4 visits))
- Insulin(From enrollment to the end of the clinical trial at 12 months (for 4 visits))
- Glycated hemoglobin(From enrollment to the end of the clinical trial at 12 months (for 4 visits))
- C-reactive protein(From enrollment to the end of the clinical trial at 12 months (for 4 visits))
- Liver enzymes(From enrollment to the end of the clinical trial at 12 months (for 4 visits))
- Fatty liver index (FLI)(From enrollment to the end of the clinical trial at 12 months (for 4 visits))
- Fibrosis-4 index (FIB-4)(From enrollment to the end of the clinical trial at 12 months (for 4 visits))
研究者
Fannie Lajeunesse-Trempe
Principal Investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval