Type 2 DiabetesNCT06239506
Novel Brominated and Organophosphate Flame Retardants and Type 2 Diabetes
An observational study of Type 2 Diabetes and Novel Brominated Flame Retardants, run by Xiaoling Guan at 1 site in China.
Trial summary
As alternative flame retardants (FRs), novel brominated flame retardants (NBFRs) and organophosphate flame retardants (OPFRs) are ubiquitous in environment and may cause endocrine disruption effects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Novel Brominated Flame Retardants, Organophosphate Flame Retardants
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Dec 2024
- Phase
- Observational
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: we will conduct a case-control study of 340 participants from Shandong 116 Province, East China, to evaluate the associations between serum NBFR and OPFR and risk of type 2 diabetes.
Who may be able to join
- Group of Type 2 diabetes patients:
- age 18 ~ 75 years old;
- type 2 diabetes patients diagnosed in the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) , HBA1C ≥7.0% and <10.5% ;
- patients signed informed consent.
- Control Group:
- age 18 ~ 75 years old;
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- healthy population recruited from the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) ;
- living in the monitoring area for more than 6 months within 12 months;
- normal thyroid function and no history of thyroid cancer were needed in the control group;
- Fasting Blood Glucose level of 0.7 mmol/l was needed in the Control Group of Type 2 diabetes Mellitus Without History of diabetes;
- patients with informed consent.
Who cannot join
- Group of Type 2 diabetes:
- pregnant, lactating women, patients with acute cardiac cerebrovascular disease;
- patients with severe liver and Renal Impairment (related laboratory tests more than 2 times the normal) ;
- patients with Type 1 diabetes;
- participants in other clinical trials within 3 months;
- patients with malignant tumors.
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- has the disease and so on serious anemia, is not suitable to carry on the patient which the blood draws the test.
- Control Group:
- patients with serious heart, liver or kidney disease;
- patients with iodine or Thyroid hormone;
- patients with confirmed malignant tumor;
- pregnant women or those who have recently taken contraception or estrogen.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000
Guan X, Dr., 8613356677195, gxlwho@163.com
Jiao Wenjiao, Dr., 860531-89269890, Qykyc309@163.com
About this study
Official title: Exposure to Novel Brominated and Organophosphate Flame Retardants and Associations With Type 2 Diabetes
As alternative flame retardants (FRs), novel brominated flame retardants (NBFRs) and organophosphate flame retardants (OPFRs) are ubiquitous in environment and may cause endocrine disruption effects. The associations between traditional endocrine-disrupting chemicals (EDCs) and type 2 diabetes have been extensively reported in epidemiological studies. To date, however, human-based evidence on the effects of NBFRs and OPFRs is lacking. The investigators conducted a case-control study of 344 participants aged 25-80 years from Shandong Province, East China, to assess potential associations between serum NBFR and OPFR concentrations and etiology of type 2 diabetes for the first time.
Read the detailed description
In this study, the investigators conducted a case-control study in Shandong Province, East China, to evaluate the associations between serum NBFR and OPFR and risk of type 2 diabetes. The aims of the present study were to (1) evaluate the associations between alternative FRs in human serum and the risk of type 2 diabetes, (2) assess the relationships between alternative FR concentrations and fasting plasma glucose (FPG), (3) investigate the correlations between alternative FRs and concentrations of lipid fractions, including TG, TC, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C), and (4) clarify the joint effects of NBFR and OPFR mixtures on the risk of type 2 diabetes
- Conditions
- Type 2 Diabetes, Novel Brominated Flame Retardants, Organophosphate Flame Retardants, Fasting Plasma Glucose
- Being tested
- no intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetes | Case group participants were recruited from patients diagnosed with type 2 diabetes and undergoing medical treatment at the First Affiliated Hospital of Shandong First Medical University(Shandong Provincial hospital) Receives: Other: no intervention | |
| Control group | Control group participants were recruited from residents living in Jinan and undergoing physical examinations at the same hospital. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
alternative FRs
Determination of FRs was performed by a gas chromatography triple quadrupole mass spectrometry (GC-MS/MS, TQ-8050NX, Shimadzu, Japan) equipped with an electron ionization (EI+) ion source.
Measured: 2022.1-2024.12
Secondary outcomes (1)
levels of FPG
Detecting blood sugar using a biochemical analyzer
Measured: 2022.1-2024.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Jan 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaoling Guan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoling Guan, Qianfoshan Hospital
- Investigators
- Tian Hui, Dr., Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239506
- Sponsor's protocol ID
- YXLL-KY-2021-064-1
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure to Novel Brominated and Organophosphate Flame Retardants and Associations With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06239506
- Acronym / sponsor ID
- YXLL-KY-2021-064-1
- Conditions
- Type 2 Diabetes, Novel Brominated Flame Retardants, Organophosphate Flame Retardants, Fasting Plasma Glucose
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Xiaoling GuanUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 2 Feb 2024 (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.
As alternative flame retardants (FRs), novel brominated flame retardants (NBFRs) and organophosphate flame retardants (OPFRs) are ubiquitous in environment and may cause endocrine disruption effects. The associations between traditional endocrine-disrupting chemicals (EDCs) and type 2 diabetes have been extensively reported in epidemiological studies. To date, however, human-based evidence on the effects of NBFRs and OPFRs is lacking. The investigators conducted a case-control study of 344 participants aged 25-80 years from Shandong Province, East China, to assess potential associations between serum NBFR and OPFR concentrations and etiology of type 2 diabetes for the first time.
Detailed description
In this study, the investigators conducted a case-control study in Shandong Province, East China, to evaluate the associations between serum NBFR and OPFR and risk of type 2 diabetes. The aims of the present study were to (1) evaluate the associations between alternative FRs in human serum and the risk of type 2 diabetes, (2) assess the relationships between alternative FR concentrations and fasting plasma glucose (FPG), (3) investigate the correlations between alternative FRs and concentrations of lipid fractions, including TG, TC, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C), and (4) clarify the joint effects of NBFR and OPFR mixtures on the risk of type 2 diabetes
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetes | – | Other: no interventionCase group participants were recruited from patients diagnosed with type 2 diabetes and undergoing medical treatment at the First Affiliated Hospital of Shandong First Medical University(Shandong Provincial hospital) |
| Control group | – | Other: no interventionControl group participants were recruited from residents living in Jinan and undergoing physical examinations at the same hospital. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- we will conduct a case-control study of 340 participants from Shandong 116 Province, East China, to evaluate the associations between serum NBFR and OPFR and risk of type 2 diabetes.
Key inclusion criteria (11 listed)
- age 18 ~ 75 years old;
- type 2 diabetes patients diagnosed in the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) , HBA1C ≥7.0% and <10.5% ;
- patients signed informed consent.
- age 18 ~ 75 years old;
- healthy population recruited from the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) ;
Key exclusion criteria (12 listed)
- Group of Type 2 diabetes:
- patients with serious heart, liver or kidney disease;
- patients with iodine or Thyroid hormone;
- patients with confirmed malignant tumor;
- pregnant women or those who have recently taken contraception or estrogen.
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 |
|---|---|---|
| no interventionno intervention | Other | Control group, type 2 diabetes |
Primary outcome
alternative FRs
Time frame: 2022.1-2024.12
Determination of FRs was performed by a gas chromatography triple quadrupole mass spectrometry (GC-MS/MS, TQ-8050NX, Shimadzu, Japan) equipped with an electron ionization (EI+) ion source.
1 secondary outcome
levels of FPG
Time frame: 2022.1-2024.12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Tian Hui, Dr. principal investigator
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Novel Brominated Flame Retardants, run by Xiaoling Guan at 1 site in China.
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 11 inclusion and 12 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 2 Feb 2024. 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 China. 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 Guan Xiaoling, Dr. (8613356677195, gxlwho@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alternative FRs (time frame: 2022.1-2024.12). 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 2 Feb 2024.