Novel Brominated and Organophosphate Flame Retardants and Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239506
• Other study ID #: YXLL-KY-2021-064-1
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: Qianfoshan Hospital
• Contact: Guan Xiaoling, Dr.
• Phone: 8613356677195
• Email: gxlwho[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fasting Plasma Glucose
• Type 2 Diabetes

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoling Guan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	levels of FPG	Detecting blood sugar using a biochemical analyzer	2022.1-2024.12