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Novel Brominated and Organophosphate Flame Retardants and Type 2 Diabetes

Exposure to Novel Brominated and Organophosphate Flame Retardants and Associations With Type 2 Diabetes

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06239506
Enrollment
340
Registered
2024-02-02
Start date
2022-01-01
Completion date
2024-12-30
Last updated
2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fasting Plasma Glucose, Novel Brominated Flame Retardants, Organophosphate Flame Retardants, 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

Interventions

OTHERno intervention

no intervention

Sponsors

Xiaoling Guan
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
alternative FRs2022.1-2024.12Determination 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.

Secondary

MeasureTime frameDescription
levels of FPG2022.1-2024.12Detecting blood sugar using a biochemical analyzer

Countries

China

Contacts

Primary ContactGuan Xiaoling, Dr.
gxlwho@163.com8613356677195
Backup ContactJiao Wenjiao, Dr.
Qykyc309@163.com860531-89269890

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026