Association Between Persistent Organic Pollutants and Type 2 Diabetes /Thyroid Cancer

Type 2 Diabetes Clinical Trial

Official title:

Association Between Persistent Organic Pollutants and Type 2 Diabetes /Thyroid Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218395
• Other study ID #: YXLL-KY-2021(064)
• Status: Recruiting
• Start date: December 20, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2022
• Source: Qianfoshan Hospital
• Contact: Xiaoling Guan
• Phone: 8613356677195
• Email: gxlwho[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Persistent organic pollutants (POPs) are a class of organic pollutants in the environment characterized by persistent, bioaccumulation, long-range transport and biological toxicity. Due to its widespread distribution in the environment and Lipophilicity, POPs can bioaccumulate along the food chain and eventually accumulate in the human body. There are many types of POPs, including dioxins, polychlorinated biphenyls (PCBs) , polybrominated diphenyl ethers (PBDEs) and organochlorine pesticides (OCPs) . POPs is ubiquitous and Lipophilic in the environment, so the potential harm of POPs to human body has aroused wide concern. A growing number of studies have found that exposure to POPs may be associated with an increased risk of endocrine disease, particularly type 2 diabetes and thyroid cancer. The aim of this study was to assess the effect of Persistent organic pollutant exposure on the development ofType 2 diabetes and thyroid cancer by analyzing serum Persistent organic pollutant concentrations in controls, and patients with Type 2 diabetes and thyroid cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 30, 2025
• Est. primary completion date: December 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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.

Group of Thyroid Cancer patients:

1. age 18 ~ 75 years old;

2. thyroid cancer patients diagnosed in the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) ;

3. patients who signed the informed consent form.

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.

Group of Thyroid Cancer:

1. patients with serious heart, liver and Kidney Diseases (related laboratory tests more than 2 times normal) ;

2. patients with other malignant tumors.

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
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Type 2 Diabetes

Locations

Country	Name	City	State
China	Xiaoling Guan	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Qianfoshan Hospital	Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the risk of Persistent organic pollutant exposure to type 2 diabetes	to explore the effect of Persistent organic pollutant on the risk of type 2diabetes	2021.11 Ethics Committee Approval 2021.12-2024.12 controls/patients recruitment, samples test 2025.1-2024.12 data analysis
Secondary	To assess the risk of Persistent organic pollutant exposure to thyroid cancer	to explore the effect of Persistent organic pollutant on the risk of thyroid cancer	2021.11 Ethics Committee Approval 2021.12-2024.12 controls/patients recruitment, samples test 2025.1-2024.12 data analysis