NCT04194515Unknown不适用
Gut Microbiota and Bile Acids Mediate the Clinical Benefits of Metformin and YH1 in Patients With Treatment-naïve Type 2 Diabetes Mellitus: A Pilot Observational Study
Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- bile acid profile
研究概览
简要总结
The investigators will evaluate the stool microbiota, serum and fecal bile acid composition, and changes in blood glucose and lipid profile before and after one month of metformin or YH1 treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Treatment-naïve male patients with type 2 diabetes;
- •Aged 20-65 years;
- •Body mass index (BMI) ≥ 24 kg/m2; 4.7 % ≤ glycated hemoglobin (HbA1c) < 9 %;
- •5.Low-density cholesterol (LDL-C) ≥ 130 mg/dl; 6.Expected to receive metformin 500 mg tid or YH1 6g tid for one month
排除标准
- •type 1,or other specific types of diabetes;
- •history of oral hypoglycemic agents (OHAs) treatment or insulin therapy;
- •use of lipid-lowering drugs within the past six months;
- •serious gastrointestinal (GI) tract diseases, including peptic ulcers and GI tract bleeding;
- •hepatic insufficiency with ALT >72 U/L or renal insufficiency with an eGFR < 60 mL/min/1.73 m2;
- •history of stressful situations, including diabetic ketoacidosis, nonketotic hyperosmolar diabetic coma, infectious disease, or surgery in the previous month;
- •mental illness;
- •current smoking status, alcohol or drug abuse;
- •hemoglobin disease or chronic anemia;
- •underlying conditions that could lead to poor compliance;
- •severe organic diseases, including cancer, coronary heart disease, myocardial infarction or cerebrovascular disease;
- •continuous antibiotic or probiotics use for over 3 days within 3 months prior to enrollment;
- •continuous use of weight loss drug for over 1 month;
- •history of YH1 therapy, or Chinese medicine treatment within the past one month.
研究组 & 干预措施
YH1 group
干预措施: YH1 (Drug)
Metformin group
干预措施: metformin (Drug)
结局指标
主要结局
bile acid profile
时间窗: one month
before and after YH1 or metformin treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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