NCT05177250

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 20, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

December 9, 2021

Last Update Submit

July 26, 2022

Conditions

Type2 DiabetesBisphenol A

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Case group

OTHER

50 cases with type 2 DM.

Device: HPLC

Control group

OTHER

50 subjects not diabetics.

Device: HPLC

Interventions

HPLCDEVICE

taking urine samples from participants and analyze these samples to detect bisphenol A and paraben

Case groupControl group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Fathy

Cairo, 00, Egypt

RECRUITING

MeSH Terms

Interventions

Chromatography, High Pressure Liquid

Intervention Hierarchy (Ancestors)

Chromatography, LiquidChromatographyChemistry Techniques, AnalyticalInvestigative Techniques

Central Study Contacts

Ahmed Awad, PHD

CONTACT

201063348234Drahmedfathy8090@kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of forensic medicine and clinical toxicology

Study Record Dates

First Submitted

December 9, 2021

First Posted

January 4, 2022

Study Start

February 20, 2022

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)