Association of Bisphenol A,Paraben Exposure and Type 2 Diabetes

Not Applicable

• Conditions: Bisphenol A; Type2 Diabetes
• Interventions: Device: HPLC

• Registration Number: NCT05177250
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2022-01-04
• Study Start: 2022-02-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27
• Primary Completion: 2022-12-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case group	HPLC	50 cases with type 2 DM.
Control group	HPLC	50 subjects not diabetics.

Primary Outcome Measures

Name	Time	Method
Bisphenol A and paraben detection in urine samples of diabetic (n=50) and non diabetic persons (n=50)	Baseline	Evaluation of bisphenol A and Paraben detection in urine samples from type 2 diabetic adult patients compared with non diabetic persons using HPLC

Trial Locations

Locations (1)

Ahmed Fathy; 🇪🇬 Cairo, Egypt