jRCT1031230422招募中不适用
Single-center exploratory study: Evaluation of therapeutic impact GLP-1 a gonist on glucose and lipid metabolism and fatty liver disease in obesity u sing genomic information
未提供0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Diagnostic Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 75age old not（—）
- 性别
- All
入选标准
- •Obese patients with a BMI of 30.0 kg/m2 or higher who have glucose intolerance, dyslipidemia, and fatty liver disease, as defined by the Japan Society for the Study of Obesity
- •Patients who are at least 18 years old and less than 75 years old at the time of consent
- •Patients who have been fully informed of the study and who have given written consent of their own free will after sufficient understanding of the study
排除标准
- •Persons who meet any of the following conditions are not eligible
- •Secondary obesity (symptomatic obesity) 2)Patients with a history of wasting disease or condition (severe infection, invasive surgery, malignancy, severe trauma, hyperthyroidism, etc.) that causes extreme weight loss within the past 6 months from the date of consent
- •Patients with severe diabetes mellitus with an H bA1c of 10% or higher
- •Patients with severe hypertension (systolic blood pressure > 180 mmHg)
- •Patients with severe cardiopulmonary, renal, or hepatic dysfunction that is not an indication for exercise therapy
- •Patients with serious musculoskeletal disorders that are not indications for exercise therapy
- •Patients with psychiatric disorders that are difficult to manage
- •Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating
- •Patients who are unable to obtain written consent or who do not understand the outline or purpose of the study
- •Other patients who are deemed by the investigator or sub investigator to be unsuitable for the safe conduct of the study
结局指标
主要结局
-
Relevance of HbA1c changed at 12 months (%) to genotype
次要结局
- Reduction in visceral fat mass(12 months)
- Change in body fat and lean body mass(12 months)
- Percentage change in liver function (AST, ALT, G-GTP)(12 months)
- Percent change in systolic and diastolic blood pressure(6 and 12 months)
- Percent weight loss(6 and 12 months)
- Percent change in HbA1c(6 months)
- Percentage change in serum lipids(6 and 12 months)
- Degree of improvement in health problems of obesity-related diseases(12 months)
- Percentage of reduction of medication for health problems(6 and 12 months)
- Change in liver hardness measured by abdominal ultrasound (VCTE)
- Hepatocyte gene expression change(12 months)
- NAFLD activity score (NAS) change using liver biopsy histopathology
- Frequency of adverse events
- Sudden death
- Cardiovascular events
- Stroke
- Onset of malignancy
- Onset or worsening of psychiatric disorders
- Frequency of onset or worsening of musculoskeletal disorders
研究者
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