Type2 DiabetesNCT05177250
Association of Bisphenol A,Paraben Exposure and Type 2 Diabetes
A study testing HPLC in people with Type2 Diabetes and Bisphenol A, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the association between BPA , paraben levels and type 2 DM patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes, Bisphenol A
- What is being tested?
- HPLC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2022to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients ( 18 y or elder).
- Type 2 DM
Who cannot join
- Type 1 DM
- Less than 18 y
- History of chronic diseases such as liver failure, cardiac patients……etc
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Fathy
Cairo, 00
Ahmed Fathy, 000000000, Drahmed.fathy8090@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Type2 Diabetes, Bisphenol A
- Being tested
- HPLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPLCDevice
taking urine samples from participants and analyze these samples to detect bisphenol A and paraben
| Study group | Role | What they receive |
|---|---|---|
| Case group | Other | 50 cases with type 2 DM. Receives: Device: HPLC |
| Control group | Other | 50 subjects not diabetics. Receives: Device: HPLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start20 Feb 2022
- Primary completion1 Dec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Fathy Hussein Awad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177250
- Sponsor's protocol ID
- bisphenol A,paraben, type 2DM
- Status last verified
- Jul 2022
- First submitted
- 9 Dec 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Association Between Bisphenol A, Paraben Exposure and Type 2 Diabetic Adult Patients.
- ClinicalTrials.gov ID
- NCT05177250
- Acronym / sponsor ID
- bisphenol A,paraben, type 2DM
- Conditions
- Type2 Diabetes, Bisphenol A
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Other | Device: HPLC50 cases with type 2 DM. |
| Control group | Other | Device: HPLC50 subjects not diabetics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients ( 18 y or elder).
- Type 2 DM
Key exclusion criteria (3 listed)
- Type 1 DM
- Less than 18 y
- History of chronic diseases such as liver failure, cardiac patients……etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPLCtaking urine samples from participants and analyze these samples to detect bisphenol A and paraben | Device | Case group, Control group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Type2 Diabetes
RecruitingPhase 3
A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
Obesity, Overweight
Recruiting
The RESET System Pivotal Clinical Trial (Protocol Revision K)
Diabetes type2, Obesity
Not yet recruiting
Diabetes Prevention AI: Enhancing Prevention Strategies Using Personalized Nutrition and Fitness Coaching for the Next Generation
Pre Diabetes, Type2 Diabetes
Active, not recruitingObservational study
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
Cardiovascular Events, Type2 Diabetes
Recruiting
SnapDandCGMinType2DM
Type2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPLC in people with Type2 Diabetes and Bisphenol A, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Awad, PHD (201063348234, Drahmedfathy8090@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bisphenol A and paraben detection in urine samples of diabetic (n=50) and non diabetic persons (n=50) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.