Investigating the link between flame retardants and type 2 diabetes

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

This study is trying to see if certain flame retardants found in everyday products are linked to a higher risk of type 2 diabetes in people aged 25 to 80.

Quick facts

• Study type: Observational
• Enrollment: 340 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06239506 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the associations between novel brominated flame retardants (NBFRs) and organophosphate flame retardants (OPFRs) in serum and the risk of type 2 diabetes. Conducted in Shandong Province, East China, it involves a case-control design with 344 participants aged 25-80 years. The study aims to assess how these chemicals may influence fasting plasma glucose levels and lipid fractions, as well as the combined effects of these flame retardants on diabetes risk. This research seeks to fill the gap in human-based evidence regarding the impact of these alternative flame retardants on endocrine disruption and diabetes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 diagnosed with type 2 diabetes or healthy individuals from the same age group living in the monitoring area.

Not a fit: Patients with acute cardiac or cerebrovascular diseases, pregnant or lactating women, and those with severe liver conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into environmental risk factors for type 2 diabetes, potentially leading to preventive measures.

How similar studies have performed: While studies have shown associations between traditional endocrine disruptors and type 2 diabetes, this specific investigation into NBFRs and OPFRs is novel and has not been extensively tested.

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.

Where this trial is running

Jinan, Shandong

• The First Affiliated Hospital of Shandong First Medical University — Jinan, Shandong, China (RECRUITING)

Study contacts

• Principal investigator: Tian Hui, Dr. — Shandong First Medical University
• Study coordinator: Guan Xiaoling, Dr.

Conditions: Type 2 Diabetes, Novel Brominated Flame Retardants, Organophosphate Flame Retardants, Fasting Plasma Glucose