Association of Bisphenol A,Paraben Exposure and Type 2 Di... | NCT05177250

Studies
Association of Bisphenol A,Paraben Exposure and Type 2 Diabetes

NCT05177250

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jul 27, 2022Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Type2 Diabetes
Bisphenol A

Interventions

HPLC

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2022Actual

Primary Completion Date

Dec 1, 2022Estimated

Completion Date

Jan 2023Estimated

First Submitted Date

Dec 9, 2021

First Submission Date that Met QC Criteria

Dec 15, 2021

First Posted Date

Jan 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2022

Last Update Posted Date

Jul 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Fathy Hussein Awad, Assistant lecturer of forensic medicine and clinical toxicology, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case group	Other	50 cases with type 2 DM.	Device: HPLC
Control group	Other	50 subjects not diabetics.	Device: HPLC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HPLC	Device	taking urine samples from participants and analyze these samples to detect bisphenol A and paraben	Case group Control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients ( 18 y or elder).
Type 2 DM

Exclusion Criteria:

Type 1 DM
Less than 18 y
History of chronic diseases such as liver failure, cardiac patients……etc

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Awad, PHD	Contact	201063348234		Drahmedfathy8090@kasralainy.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Fathy	Recruiting	Cairo		00	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002851	Chromatography, High Pressure Liquid

Ancestor Terms

ID	Term
D002853	Chromatography, Liquid
D002845	Chromatography
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided