Association of Bisphenol A,Paraben Exposure and Type 2 Diabetes

Type2 Diabetes Clinical Trial

Official title:

The Possible Association Between Bisphenol A, Paraben Exposure and Type 2 Diabetic Adult Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177250
• Other study ID #: bisphenol A,paraben, type 2DM
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2022
• Est. completion date: January 2023

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: Ahmed Awad, PHD
• Phone: 201063348234
• Email: Drahmedfathy8090[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the association between BPA , paraben levels and type 2 DM patients

Description:

The first phase of the study will include a questionnaire :

• The cases and control will be asked about demographic information such as residence, age, education, and occupation.

• History of discovery of diabetes.

• Exposure to products and materials such as polycarbonate plastics, cosmetics and beverages containing bisphenol A and paraben and it will be evaluated through exposure sheet through asking about dietary exposure, Environmental exposure and medical exposure.

Then clinical evaluation including:

• Full clinical examination will be performed for cases and control.

• Anthropological data:

their weights, heights and waist circumference will be measured. The body mass index (BMI) will be calculated by weight (kg)/height (m)2 formula.

• Investigations: routine and specific investigation as blood glucose level, HbA1c and lipid profile.

• Urine specimens will be collected in clean, glass containers will labeled with the subject identification number. Turbid sample or those containing blood will be excluded.

• All specimens will be stored frozen below 20 degree centigrade.

• Urine samples will be analyzed by High Performance liquid chromatograph (HPLC) to detect bispenol A and parabens levels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients ( 18 y or elder).

2. Type 2 DM

Exclusion Criteria:

• Type 1 DM

• Less than 18 y

• History of chronic diseases such as liver failure, cardiac patients……etc

Related Conditions & MeSH terms

• Bisphenol A
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Device:
• HPLC
taking urine samples from participants and analyze these samples to detect bisphenol A and paraben

Locations

Country	Name	City	State
Egypt	Ahmed Fathy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bisphenol A and paraben detection in urine samples of diabetic (n=50) and non diabetic persons (n=50)	Evaluation of bisphenol A and Paraben detection in urine samples from type 2 diabetic adult patients compared with non diabetic persons using HPLC	Baseline