Seum Bile Acid Profile in Type 2 Diabetes and Association Between Bile Cid Profile and Adipokine or Oxidative Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- bile acid profile
研究概览
简要总结
"The goal of this work is to critically test the hypothesis that there exists a different profile of bile acids (BAs) in patient with type 2 diabetes mellitus (T2DM) compared with normal controls. Through confirmation of different profile of BAs in T2DM, investigator will suggest modulation of specific bile acids as a new possible treatment target in patients with T2DM. Investigator also expect the specific BAs signature will be used to screen T2DM before hyperglycemia.
In addition, investigator will evaluate the association between each BA species and serum total glucagon like peptide-1 (GLP-1) or fibroblast growth factor-19 (FGF-19) concentrations to determine if the specific BAs profile is related with total GLP-1 or FGF-19 concentration in serum. Investigatr also evaluates the correlation between each BA species and metabolic profiles and oxidative stress marker to find possible roles of each BA component in glucose metabolism.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •pre-diabetes
- •defined according to the ADA guideline (prediabetes definition) FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) or 2-h PG in the 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (IGT) or A1C 5.7-6.4% (39-46 mmol/mol)
- •type 2 diabetes
- •defined according to the ADA guideline (DM definition) FPG ≥126 mg/dL (7.0 mmol/L) or 2-h PG ≥200 mg/dL (11.1 mmol/L) in the 75-g OGTT or A1C ≥6.5% (48 mmol/mol) or In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L) or
- •taking any anti-diabetic medications
- •Normal control
- •should not be included in other groups as above and
- •not taking any medication related to diabetes and dyslipidemia and
- •BMI <25kg/m2
排除标准
- •subjects who refused to agree with informed consents
- •subjects with organ-transplantation
- •pregnant women
- •type 1 diabetes -
结局指标
主要结局
bile acid profile
时间窗: 8h fasting blood sample
Bile acids profile to predict T2DM will be measured using high performance liquid chromatography-tandem mass spectrometry.
次要结局
未报告次要终点