Novel Brominated and Organophosphate Flame Retardants and Type 2 Diabetes

Xiaoling Guan

Status: Enrolling

Conditions: Organophosphate Flame Retardants; Novel Brominated Flame Retardants; Fasting Plasma Glucose; Type 2 Diabetes

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06239506

YXLL-KY-2021-064-1

Details and patient eligibility

About

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.

Full description

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

Enrollment: 340 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Group of Type 2 diabetes patients:

1. age 18 ~ 75 years old;
2. 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% ;
3. patients signed informed consent.

Control Group:

1. age 18 ~ 75 years old;
2. healthy population recruited from the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) ;
3. living in the monitoring area for more than 6 months within 12 months;
4. normal thyroid function and no history of thyroid cancer were needed in the control group;
5. Fasting Blood Glucose level of 0.7 mmol/l was needed in the Control Group of Type 2 diabetes Mellitus Without History of diabetes;
6. patients with informed consent.

Exclusion criteria

• Group of Type 2 diabetes:

  1. pregnant, lactating women, patients with acute cardiac cerebrovascular disease;
  2. patients with severe liver and Renal Impairment (related laboratory tests more than 2 times the normal) ;
  3. patients with Type 1 diabetes;
  4. participants in other clinical trials within 3 months;
  5. patients with malignant tumors.
  6. has the disease and so on serious anemia, is not suitable to carry on the patient which the blood draws the test.

Control Group:

1. patients with serious heart, liver or kidney disease;
2. patients with iodine or Thyroid hormone;
3. patients with confirmed malignant tumor;
4. pregnant women or those who have recently taken contraception or estrogen.

Trial design

340 participants in 2 patient groups

type 2 diabetes

Description:

Case group participants were recruited from patients diagnosed with type 2 diabetes and undergoing medical treatment at the First Affiliated Hospital of Shandong First Medical University(Shandong Provincial hospital)

Treatment:

Other: no intervention

Control group

Description:

Control group participants were recruited from residents living in Jinan and undergoing physical examinations at the same hospital.

Treatment:

Other: no intervention