Association of Bisphenol A,Paraben Exposure and Type 2 Diabetes
Primary Purpose
Type2 Diabetes, Bisphenol A
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
HPLC
Sponsored by
About this trial
This is an interventional screening trial for Type2 Diabetes
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
Sites / Locations
- Ahmed FathyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Case group
Control group
Arm Description
50 cases with type 2 DM.
50 subjects not diabetics.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05177250
Brief Title
Association of Bisphenol A,Paraben Exposure and Type 2 Diabetes
Official Title
The Possible Association Between Bisphenol A, Paraben Exposure and Type 2 Diabetic Adult Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Bisphenol A
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Case group
Arm Type
Other
Arm Description
50 cases with type 2 DM.
Arm Title
Control group
Arm Type
Other
Arm Description
50 subjects not diabetics.
Intervention Type
Device
Intervention Name(s)
HPLC
Intervention Description
taking urine samples from participants and analyze these samples to detect bisphenol A and paraben
Primary Outcome Measure Information:
Title
Bisphenol A and paraben detection in urine samples of diabetic (n=50) and non diabetic persons (n=50)
Description
Evaluation of bisphenol A and Paraben detection in urine samples from type 2 diabetic adult patients compared with non diabetic persons using HPLC
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Awad, PHD
Phone
201063348234
Email
Drahmedfathy8090@kasralainy.edu.eg
Facility Information:
Facility Name
Ahmed Fathy
City
Cairo
ZIP/Postal Code
00
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Fathy
Phone
000000000
Email
Drahmed.fathy8090@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Association of Bisphenol A,Paraben Exposure and Type 2 Diabetes
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