Effect of Mutations in T2DM Susceptibility Genes on the Expression of Susceptibility Genes in Patients With T2DM and Controls
Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University
1 other identifier
interventional
300
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Jan 2024
Longer than P75 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 5, 2024
CompletedFirst Posted
Study publicly available on registry
February 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
February 28, 2024
February 1, 2024
4.1 years
February 5, 2024
February 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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
6 months after obtaining the clinicopathological results
Secondary Outcomes (16)
Baseline BMI of newly diagnosed with T2DM patients with different genotypes
1 month of completion for individual screening
Baseline waist hip ratio (WHR) of newly diagnosed with T2DM patients with different genotypes
1 month of completion for individual screening
Baseline fasting plasma glucose (FPG) of newly diagnosed with T2DM patients with different genotypes
1 month of completion for individual screening
Baseline HbA1c of newly diagnosed with T2DM patients with different genotypes
1 month of completion for individual screening
Baseline TC of newly diagnosed with T2DM patients with different genotypes
1 month of completion for individual screening
- +11 more secondary outcomes
Study Arms (1)
Comparison of T2DM susceptibility gene expression between newly diagnosed T2DM patients and controls
EXPERIMENTALTo 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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）.
- 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）.
- 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）.
You may not qualify if:
- had taken antidiabetic drugs;
- had a history of pancreatic surgery;
- Complicated with severe organ lesions;
- Long-term use of drugs that affect pancreatic function.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China, Jiangsu, Department of Endocrinology
Xuzhou, 221006, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2024
First Posted
February 26, 2024
Study Start
January 1, 2024
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
January 31, 2028
Last Updated
February 28, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share