Metagenomic Analysis of Human Gut Microbiota in Patients With Metabolic Diseases Including Diabetes.
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Metagenomic profile change
研究概览
简要总结
Microbiota is important for immunology, hormonal and metabolic homeostasis in human and could influence on developing diabetes and obesity. Recent studies investigates microbiota by metagenomic sequencing, however, the composite of microbiota and its metabolic role has not been fully determined. Metagenomics and microbiome analysis could early diagnose metabolic disorders and suggest treatment options for metabolic diseases.
In this study, the investigators investigate the composite of microbiota and deduct basic information for treatment models using metagenomic sequencing.
详细描述
- Cross-section study: normal/prediabetes/drug naïve type2 diabetes: compare microbiota using metagenomic sequencing among three groups.
- Observational prospective study: metformin/sodium glucose co-transporter 2 (SGLT2) inhibitor/ezetimibe: compare microbiota using metagenomic sequencing before and after drug 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •normal group: body mass index [BMI]<23kg/m2, without diabetes mellitus history
- •prediabetes group: fasting blood glucose ≥100 mg/dL and <126 mg/dL or postprandial blood glucose ≥140 mg/dL and <200 mg/dL
- •type 2 diabetes according to ADA(American Diabetes Association) guideline (1) fasting blood glucose ≥126 mg/dL, (2) random blood glucose ≥200 mg/dL and with typical diabetes symptoms, (3) glycated hemoglobin A1c ≥6.5% and anti-hypoglycemic drug naive
- •patients with type 2 diabetes, metformin monotherapy, SGLT2 inhibitor monotherapy
- •patients with dyslipidemia, ezetimibe therapy
排除标准
- •inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- •history of stomach, small intestine or colon resection operation
- •on antibiotics therapy
研究组 & 干预措施
normal group
normal group (without diabetes diagnosis/treatment and in normoglycemia
干预措施: Metformin (Other)
normal group
normal group (without diabetes diagnosis/treatment and in normoglycemia
干预措施: ezetimibe (Drug)
prediabetes
high risk, impaired fasting glucose, impaired glucose tolerance
干预措施: Metformin (Other)
prediabetes
high risk, impaired fasting glucose, impaired glucose tolerance
干预措施: ezetimibe (Drug)
drug naive type 2 diabetes
type 2 diabetes, anti-hypoglycemic drug naive
干预措施: Metformin (Other)
drug naive type 2 diabetes
type 2 diabetes, anti-hypoglycemic drug naive
干预措施: ezetimibe (Drug)
type 2 diabetes with metformin monotherapy
type 2 diabetes with metformin monotherapy
干预措施: Metformin (Other)
type 2 diabetes with SGLT2 inhibitor monotherapy
type 2 diabetes with SGLT2 inhibitor monotherapy
干预措施: SGLT2 inhibitor (Drug)
dyslipidemia with ezetimibe therapy
dyslipidemia with ezetimibe therapy
干预措施: ezetimibe (Drug)
结局指标
主要结局
Metagenomic profile change
时间窗: 3 months (chronic effect)
Stool metagenomic profile change in acute and chronic phase
次要结局
- blood glucose change(3 months)