Clinical trial NCT06239506: Novel Brominated and Organophosphate Flame Retardants and Type 2 Diabetes
Official title: Exposure to Novel Brominated and Organophosphate Flame Retardants and Associations With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Novel Brominated Flame Retardants
Organophosphate Flame Retardants
Fasting Plasma Glucose
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: we will conduct a case-control study of 340 participants from Shandong 116 Province, East China, to evaluate the associations between serum NBFR and OPFR and risk of type 2 diabetes.

Brief summary: 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: alternative FRs
timeFrame: 2022.1-2024.12
Secondary outcomes:
measure: levels of FPG
timeFrame: 2022.1-2024.12
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Tian Hui, Dr.
role: PRINCIPAL_INVESTIGATOR
References: