Therapeutic Effect of Semaglutide on Nonalcoholic Fatty Liver Disease in Obesity and/or Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- NAFLD regression
研究概览
简要总结
The goal of this clinical trial is to test the therapeutic effect of Semaglutide in NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus. The main question it aims to answer is:
• Is the use of Semaglutide (oral or subcutaneous form) effective in improving NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus?
Participants will undergo:
- Abdominal ultrasound.
- Fibroscan with controlled attenuation parameter to assess liver stiffness (kPa) and liver steatosis (dB/m).
- Fibrosis-4 score requires values of age, alanine aminotransferase, aspartate aminotransferase, and platelet count.
- NAFLD Fibrosis Score requires values of age, BMI, platelet count, albumin, hyperglycemia, and ALT/AST ratio.
Researchers will compare:
- Group 1 will receive oral Semaglutide for 48 weeks.
- Group 2 will receive injectable Semaglutide for 48 weeks.
- Group 3 will receive Pioglitazone and/or Vitamin E. to see if there is an improvement in liver stiffness and severity of hepatic steatosis after 48 weeks.
详细描述
Rationale:
NAFLD is one of the major causes of chronic liver disease worldwide with the highest prevalence in Middle East countries. No pharmaceutical agent until now approved to treat hepatic steatosis. There is a potential effect of glucagon-like peptide-1 agonists in the treatment of steatosis and improving the resulting steatohepatitis and fibrosis in obesity and/or type 2 diabetes mellitus.
Research question:
Is the use of Semaglutide (oral or SC form) effective in improving NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus?
Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with NAFLD by non-invasive methods in the form of abdominal US or MRI, confirmed by a Fibroscan scan with CAP to assess the quantity of hepatic steatosis and severity of fibrosis up to 21 weeks before the start of the study and after treatment.
- •Primary obesity with body mass index (BMI) >
- •Type 2 diabetes mellitus.
排除标准
- •Type 1 diabetes mellitus.
- •DM, which is treated with insulin glargine.
- •Alcohol consumption.
- •Patients had bariatric surgery.
- •Hepatitis C virus, hepatitis B virus, HIV.
- •Patients with peptic ulcer disease.
- •Secondary obesity originated from hypothalamic or endocrinal disorders.
- •Other causes of CLD.
- •Decompensated liver disease.
- •History of pancreatitis (acute or chronic).
- •Hepato-biliary disorders.
- •ALT and AST values > 5 times of upper normal limits.
- •Severe cardiac disease.
- •Patients treated with GLP-1 agonist within 90 days before screening.
- •Patients with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
研究组 & 干预措施
NAFLD1
Hepatic steatosis
干预措施: Rybelsus Oral Product (Drug)
NAFLD2
Hepatic steatosis
干预措施: Ozempic Injectable Product (Drug)
NAFLD3
Hepatic steatosis
干预措施: Tocopherol and/or Actos (Drug)
结局指标
主要结局
NAFLD regression
时间窗: 48 weeks
improvement of severity of hepatic steatosis evaluated by CAP (dB/m)
次要结局
- Fibrosis regression(48 weeks)
研究者
Ayman Magd Eldin Mohammad Sadek
Associate Professor of Internal Medicine
Zagazig University