Exposure to Novel Brominated and Organophosphate Flame Retardants and Associations With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- alternative FRs
研究概览
简要总结
As alternative flame retardants (FRs), novel brominated flame retardants (NBFRs) and organophosphate flame retardants (OPFRs) are ubiquitous in environment and may cause endocrine disruption effects. The associations between traditional endocrine-disrupting chemicals (EDCs) and type 2 diabetes have been extensively reported in epidemiological studies. To date, however, human-based evidence on the effects of NBFRs and OPFRs is lacking. The investigators conducted a case-control study of 344 participants aged 25-80 years from Shandong Province, East China, to assess potential associations between serum NBFR and OPFR concentrations and etiology of type 2 diabetes for the first time.
详细描述
In this study, the investigators conducted a case-control study in Shandong Province, East China, to evaluate the associations between serum NBFR and OPFR and risk of type 2 diabetes. The aims of the present study were to (1) evaluate the associations between alternative FRs in human serum and the risk of type 2 diabetes, (2) assess the relationships between alternative FR concentrations and fasting plasma glucose (FPG), (3) investigate the correlations between alternative FRs and concentrations of lipid fractions, including TG, TC, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C), and (4) clarify the joint effects of NBFR and OPFR mixtures on the risk of type 2 diabetes
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Group of Type 2 diabetes patients:
- •age 18 ~ 75 years old;
- •type 2 diabetes patients diagnosed in the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) , HBA1C ≥7.0% and <10.5% ;
- •patients signed informed consent.
- •Control Group:
- •age 18 ~ 75 years old;
- •healthy population recruited from the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) ;
- •living in the monitoring area for more than 6 months within 12 months;
- •normal thyroid function and no history of thyroid cancer were needed in the control group;
- •Fasting Blood Glucose level of 0.7 mmol/l was needed in the Control Group of Type 2 diabetes Mellitus Without History of diabetes;
- •patients with informed consent.
排除标准
- •Group of Type 2 diabetes:
- •pregnant, lactating women, patients with acute cardiac cerebrovascular disease;
- •patients with severe liver and Renal Impairment (related laboratory tests more than 2 times the normal) ;
- •patients with Type 1 diabetes;
- •participants in other clinical trials within 3 months;
- •patients with malignant tumors.
- •has the disease and so on serious anemia, is not suitable to carry on the patient which the blood draws the test.
- •Control Group:
- •patients with serious heart, liver or kidney disease;
- •patients with iodine or Thyroid hormone;
- •patients with confirmed malignant tumor;
- •pregnant women or those who have recently taken contraception or estrogen.
结局指标
主要结局
alternative FRs
时间窗: 2022.1-2024.12
Determination of FRs was performed by a gas chromatography triple quadrupole mass spectrometry (GC-MS/MS, TQ-8050NX, Shimadzu, Japan) equipped with an electron ionization (EI+) ion source.
次要结局
- levels of FPG(2022.1-2024.12)
研究者
Xiaoling Guan
Clinical Professor
Qianfoshan Hospital