Novel Brominated and Organophosphate Flame Retardants and Type 2 Diabetes
Exposure to Novel Brominated and Organophosphate Flame Retardants and Associations With Type 2 Diabetes
1 other identifier
observational
340
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
December 11, 2023
CompletedFirst Posted
Study publicly available on registry
February 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedFebruary 2, 2024
December 1, 2023
3 years
December 11, 2023
January 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
alternative FRs
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.
2022.1-2024.12
Secondary Outcomes (1)
levels of FPG
2022.1-2024.12
Study Arms (2)
type 2 diabetes
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)
Control group
Control group participants were recruited from residents living in Jinan and undergoing physical examinations at the same hospital.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiaoling Guanlead
Study Sites (1)
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000, China
Biospecimen
Blood samples were collected in vacutainer tubes without anticoagulants. The levels of FPG, TG, TC, HDL-C, and LDL-C were measured at the above hospital. The whole blood samples in tubes were centrifuged at 4 000 r min-1 for 10 min, and were placed in two sample tubes. One n was used for determination of FPG and lipid fractions in the hospital. And the other was maintained at -20 ℃ for FRs analysis. FPG was determined enzymatically, and lipid fractions were analyzed using an enzymatic spectrophotometric method in serum . Total lipids (TLs) were counted using Phillip's formula: TL = 2.27 × TC + TG + 0.623.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tian Hui, Dr.
Shandong First Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
December 11, 2023
First Posted
February 2, 2024
Study Start
January 1, 2022
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
February 2, 2024
Record last verified: 2023-12