Type 2 Diabetes MellitusNCT06277466
Effect of Mutations in T2DM Susceptibility Genes on the Expression of Susceptibility Genes in Patients With T2DM and Controls
A study testing Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs in people with Type 2 Diabetes Mellitus and Gene Polymorphisms, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
In this study, investigators wanted to determine the effect of T2DM susceptibility gene mutations on self-expression. Participants (T2DM patients and controls) were recruited to identify genotypes and detect the levels of T2DM susceptibility genes expression in the fresh peripheral plasma. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Gene Polymorphisms, Genetic Mutations
- What is being tested?
- Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no drug therapy; 25 to 70 years old; Hemoglobin A1c (HbA1c) 7%-12%; BMI 20-35 kg/m2; Stable body weight (≤10% change within 3 months)（For newly diagnosed patients with T2DM）.
- 25 to 60 years old; BMI 19-26 kg/m2; in good health, with no abnormalities of motor system, digestive system, respiratory system, urogenital system, blood system, circulatory system, nervous/mental system, endocrine system, etc（For healthy subjects）.
- 20-80 years old; surgical resection of part or all of the pancreas; pancreatic lesions confirmed by enhanced CT or magnetic resonance (MR) examination or confirmed by intraoperative and postoperative pathology（For the patients in general surgical）.
Who cannot join
- had taken antidiabetic drugs;
- had a history of pancreatic surgery;
- Complicated with severe organ lesions;
- Long-term use of drugs that affect pancreatic function.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China, Jiangsu, Department of Endocrinology
Xuzhou, 221006
Hongwei Ling, MD, 18052268607, linghongwei@medmail.com.cn
Renguo Chen, MD
About this study
Official title: Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University
In this study, investigators wanted to determine the effect of T2DM susceptibility gene mutations on self-expression.
Participants (T2DM patients and controls) were recruited to identify genotypes and detect the levels of T2DM susceptibility genes expression in the fresh peripheral plasma. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were also collected to identify the expression differences of T2DM susceptibility genes under different genotypes.
Read the detailed description
The primary objective of this study was to investigate the changes of the expression of T2DM susceptible genes (NOS1AP, KCNQ1, TCF7L2, WSF1, GLP-1R, etc.) in participants (newly diagnosed T2DM patients and controls) after gene mutation.
Secondly, the expression differences of T2DM susceptible genes in T2DM patients with different genotypes were compared, and the relationship between the expression differences and clinicopathological characteristics of T2DM patients was analyzed.
Participants (newly diagnosed T2DM patients and healthy subjects) were screened from the department of endocrinology and health management center, whose fresh peripheral blood were collected. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected in the department of general surgery. The DNA genome was extracted for genotyping, and then the expression levels of T2DM related susceptibility genes under different genotypes were detected by ELISA kits, PCR, WB,HE staining, IHC staining, ect.
The basic information of T2DM patients was collected, including demographic characteristics, physiological and biochemical data.Then investigators further compared the differences in the expression of susceptible genes between newly diagnosed T2DM patients and controls.
- Being tested
- Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugs, Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs
- Keywords
- T2DM, gene polymorphism, susceptibility gene, genetic mutations
- Medical subject headings
- Diabetes Mellitus, Type 2, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugsDrug
Compared with newly diagnosed T2DM patients, healthy subjects in the control group had normal levels of blood glucose, lipids, glycated hemoglobin levels, etc. Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected before taking antidiabetic drugs in both groups.
Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugsDrug
The newly diagnosed T2DM group should not have taken antidiabetic drugs and meet the diagnosis of T2DM. Fresh blood samples were collected before medication for detection.
In the control group (healthy subjects), the indicators of physical examination were within the normal range and no hypoglycemic drugs were taken. Similarly, fresh blood samples should be taken for testing.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of T2DM susceptibility gene expression between newly diagnosed T2DM patients and controls | Experimental | To determine the effect of gene mutations on the susceptibility of T2DM by comparing the expression levels of T2DM susceptibility genes in newly diagnosed T2DM patients and controls. Receives: Drug: Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugs; Drug: Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of T2DM susceptibility gene expression in newly diagnosed T2DM patients
To detect the expression levels of susceptible genes in the plasma and the pancreatic tissues of newly diagnosed T2DM patients and compared with those in healthy subjects.
Measured: 1 month after fresh sample collection
Detection of T2DM susceptibility gene expression in controls
To detect the expression levels of susceptible genes in the plasma and the pancreatic tissues of controls and compared with those in newly diagnosed T2DM patients.
Measured: 1 month after fresh sample collection
Correlation between T2DM susceptibility gene expression and clinicopathological features
Incidence of clinical pancreatic diseases under expression differences in T2DM susceptibility genes
Measured: 6 months after obtaining the clinicopathological results
Secondary outcomes (16)
Baseline BMI of newly diagnosed with T2DM patients with different genotypes
Baseline BMI of newly diagnosed with T2DM patients
Measured: 1 month of completion for individual screening
Baseline waist hip ratio (WHR) of newly diagnosed with T2DM patients with different genotypes
Baseline WHR of newly diagnosed with T2DM patients
Measured: 1 month of completion for individual screening
Baseline fasting plasma glucose (FPG) of newly diagnosed with T2DM patients with different genotypes
Baseline FPG of newly diagnosed with T2DM patients
Measured: 1 month of completion for individual screening
Baseline HbA1c of newly diagnosed with T2DM patients with different genotypes
Baseline HbA1c of newly diagnosed with T2DM patients
Measured: 1 month of completion for individual screening
Baseline TC of newly diagnosed with T2DM patients with different genotypes
Baseline TC of newly diagnosed with T2DM patients
Measured: 1 month of completion for individual screening
Baseline TG of newly diagnosed with T2DM patients with different genotypes
Baseline TG of newly diagnosed with T2DM patients
Measured: 1 month of completion for individual screening
Baseline HDL-C of newly diagnosed with T2DM patients with different genotypes
Baseline HDL-C of newly diagnosed with T2DM patients
Measured: 1 month of completion for individual screening
Baseline LDL-C of newly diagnosed with T2DM patients with different genotypes
Baseline LDL-C of newly diagnosed with T2DM patients
Measured: 1 month of completion for individual screening
Baseline BMI of controls with different genotypes
Baseline BMI of controls
Measured: 1 month of completion for individual screening
Baseline WHR of controls with different genotypes
Baseline WHR of controls
Measured: 1 month of completion for individual screening
Baseline FPG of controls with different genotypes
Baseline FPG of controls
Measured: 1 month of completion for individual screening
Baseline HbA1c of controls with different genotypes
Baseline HbA1c of controls
Measured: 1 month of completion for individual screening
Baseline TC of controls with different genotypes
Baseline TC of controls
Measured: 1 month of completion for individual screening
Baseline TG of controls with different genotypes
Baseline TG of controls
Measured: 1 month of completion for individual screening
Baseline HDL-C of controls with different genotypes
Baseline HDL-C of controls
Measured: 1 month of completion for individual screening
Baseline LDL-C of controls with different genotypes
Baseline LDL-C of controls
Measured: 1 month of completion for individual screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Jan 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277466
- Sponsor's protocol ID
- XYFY2023-KL478-01
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University
- ClinicalTrials.gov ID
- NCT06277466
- Acronym / sponsor ID
- XYFY2023-KL478-01
- Keywords
- T2DM, gene polymorphism, susceptibility gene, genetic mutations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 26 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.
In this study, investigators wanted to determine the effect of T2DM susceptibility gene mutations on self-expression.
Participants (T2DM patients and controls) were recruited to identify genotypes and detect the levels of T2DM susceptibility genes expression in the fresh peripheral plasma. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were also collected to identify the expression differences of T2DM susceptibility genes under different genotypes.
Detailed description
The primary objective of this study was to investigate the changes of the expression of T2DM susceptible genes (NOS1AP, KCNQ1, TCF7L2, WSF1, GLP-1R, etc.) in participants (newly diagnosed T2DM patients and controls) after gene mutation.
Secondly, the expression differences of T2DM susceptible genes in T2DM patients with different genotypes were compared, and the relationship between the expression differences and clinicopathological characteristics of T2DM patients was analyzed.
Participants (newly diagnosed T2DM patients and healthy subjects) were screened from the department of endocrinology and health management center, whose fresh peripheral blood were collected. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected in the department of general surgery. The DNA genome was extracted for genotyping, and then the expression levels of T2DM related susceptibility genes under different genotypes were detected by ELISA kits, PCR, WB,HE staining, IHC staining, ect.
The basic information of T2DM patients was collected, including demographic characteristics, physiological and biochemical data.Then investigators further compared the differences in the expression of susceptible genes between newly diagnosed T2DM patients and controls.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of T2DM susceptibility gene expression between newly diagnosed T2DM patients and controls | Experimental | Drug: Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugs, Drug: Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugsTo determine the effect of gene mutations on the susceptibility of T2DM by comparing the expression levels of T2DM susceptibility genes in newly diagnosed T2DM patients and controls. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- no drug therapy; 25 to 70 years old; Hemoglobin A1c (HbA1c) 7%-12%; BMI 20-35 kg/m2; Stable body weight (≤10% change within 3 months)（For newly diagnosed patients with T2DM）.
- 25 to 60 years old; BMI 19-26 kg/m2; in good health, with no abnormalities of motor system, digestive system, respiratory system, urogenital system, blood system, circulatory system, nervous/mental system, endocrine system, etc（For healthy subjects）.
- 20-80 years old; surgical resection of part or all of the pancreas; pancreatic lesions confirmed by enhanced CT or magnetic resonance (MR) examination or confirmed by intraoperative and postoperative pathology（For the patients in general surgical）.
Key exclusion criteria (4 listed)
- had taken antidiabetic drugs;
- had a history of pancreatic surgery;
- Complicated with severe organ lesions;
- Long-term use of drugs that affect pancreatic function.
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 |
|---|---|---|
| Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugsCompared with newly diagnosed T2DM patients, healthy subjects in the control group had normal levels of blood glucose, lipids, glycated hemoglobin levels, etc. Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected before taking antidiabetic drugs in both groups. | Drug | Comparison of T2DM susceptibility gene expression between newly diagnosed T2DM patients and controls |
| Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugsThe newly diagnosed T2DM group should not have taken antidiabetic drugs and meet the diagnosis of T2DM. Fresh blood samples were collected before medication for detection. In the control group (healthy subjects), the indicators of physical examination were within the normal range and no hypoglycemic drugs were taken. Similarly, fresh blood samples should be taken for testing. | Drug | Comparison of T2DM susceptibility gene expression between newly diagnosed T2DM patients and controls |
Primary outcome
Detection of T2DM susceptibility gene expression in newly diagnosed T2DM patients
Time frame: 1 month after fresh sample collection
To detect the expression levels of susceptible genes in the plasma and the pancreatic tissues of newly diagnosed T2DM patients and compared with those in healthy subjects.
Detection of T2DM susceptibility gene expression in controls
Time frame: 1 month after fresh sample collection
To detect the expression levels of susceptible genes in the plasma and the pancreatic tissues of controls and compared with those in newly diagnosed T2DM patients.
Correlation between T2DM susceptibility gene expression and clinicopathological features
Time frame: 6 months after obtaining the clinicopathological results
Incidence of clinical pancreatic diseases under expression differences in T2DM susceptibility genes
16 secondary outcomes
Baseline BMI of newly diagnosed with T2DM patients with different genotypes
Time frame: 1 month of completion for individual screening
Baseline waist hip ratio (WHR) of newly diagnosed with T2DM patients with different genotypes
Time frame: 1 month of completion for individual screening
Baseline fasting plasma glucose (FPG) of newly diagnosed with T2DM patients with different genotypes
Time frame: 1 month of completion for individual screening
Baseline HbA1c of newly diagnosed with T2DM patients with different genotypes
Time frame: 1 month of completion for individual screening
Baseline TC of newly diagnosed with T2DM patients with different genotypes
Time frame: 1 month of completion for individual screening
Baseline TG of newly diagnosed with T2DM patients with different genotypes
Time frame: 1 month of completion for individual screening
Baseline HDL-C of newly diagnosed with T2DM patients with different genotypes
Time frame: 1 month of completion for individual screening
Baseline LDL-C of newly diagnosed with T2DM patients with different genotypes
Time frame: 1 month of completion for individual screening
Baseline BMI of controls with different genotypes
Time frame: 1 month of completion for individual screening
Baseline WHR of controls with different genotypes
Time frame: 1 month of completion for individual screening
Baseline FPG of controls with different genotypes
Time frame: 1 month of completion for individual screening
Baseline HbA1c of controls with different genotypes
Time frame: 1 month of completion for individual screening
Baseline TC of controls with different genotypes
Time frame: 1 month of completion for individual screening
Baseline TG of controls with different genotypes
Time frame: 1 month of completion for individual screening
Baseline HDL-C of controls with different genotypes
Time frame: 1 month of completion for individual screening
Baseline LDL-C of controls with different genotypes
Time frame: 1 month of completion for individual screening
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs in people with Type 2 Diabetes Mellitus and Gene Polymorphisms, run by The Affiliated Hospital of Xuzhou Medical University 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Wang, Ph.D (13815344640, misswt2011@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of T2DM susceptibility gene expression in newly diagnosed T2DM patients (time frame: 1 month after fresh sample collection). The study lists 3 primary outcomes in all. 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 28 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.