Novel Brominated and Organophosphate Flame Retardants and Type 2 Diabetes

January 25, 2024 updated by: Xiaoling Guan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Guan Xiaoling, Dr.
  • Phone Number: 8613356677195
  • Email: gxlwho@163.com

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • The First Affiliated Hospital of Shandong First Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Other: no intervention
no intervention
Control group
Control group participants were recruited from residents living in Jinan and undergoing physical examinations at the same hospital.
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
alternative FRs
Time Frame: 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.
2022.1-2024.12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
levels of FPG
Time Frame: 2022.1-2024.12
Detecting blood sugar using a biochemical analyzer
2022.1-2024.12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaoling Guan

Investigators

  • Principal Investigator: Tian Hui, Dr., The First Affiliated Hospital of Shandong First Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Estimated)

February 2, 2024

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YXLL-KY-2021-064-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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