Association of Bisphenol A,Paraben Exposure and Type 2 Diabetes

July 26, 2022 updated by: Ahmed Fathy Hussein Awad, Cairo University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Case group
50 cases with type 2 DM.
Device: HPLC
taking urine samples from participants and analyze these samples to detect bisphenol A and paraben
Other: Control group
50 subjects not diabetics.
Device: HPLC
taking urine samples from participants and analyze these samples to detect bisphenol A and paraben

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bisphenol A,paraben, type 2DM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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