Type 2 Diabetes Mellitus Clinical Trial
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | January 31, 2028 |
Est. primary completion date | January 31, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. 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). 2. 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). 3. 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). Exclusion Criteria: 1. had taken antidiabetic drugs; 2. had a history of pancreatic surgery; 3. Complicated with severe organ lesions; 4. Long-term use of drugs that affect pancreatic function. |
Country | Name | City | State |
---|---|---|---|
China | China, Jiangsu, Department of Endocrinology | Xuzhou |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Hospital of Xuzhou Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Baseline BMI of newly diagnosed with T2DM patients with different genotypes | Baseline BMI of newly diagnosed with T2DM patients | 1 month of completion for individual screening | |
Secondary | Baseline waist hip ratio (WHR) of newly diagnosed with T2DM patients with different genotypes | Baseline WHR of newly diagnosed with T2DM patients | 1 month of completion for individual screening | |
Secondary | Baseline fasting plasma glucose (FPG) of newly diagnosed with T2DM patients with different genotypes | Baseline FPG of newly diagnosed with T2DM patients | 1 month of completion for individual screening | |
Secondary | Baseline HbA1c of newly diagnosed with T2DM patients with different genotypes | Baseline HbA1c of newly diagnosed with T2DM patients | 1 month of completion for individual screening | |
Secondary | Baseline TC of newly diagnosed with T2DM patients with different genotypes | Baseline TC of newly diagnosed with T2DM patients | 1 month of completion for individual screening | |
Secondary | Baseline TG of newly diagnosed with T2DM patients with different genotypes | Baseline TG of newly diagnosed with T2DM patients | 1 month of completion for individual screening | |
Secondary | Baseline HDL-C of newly diagnosed with T2DM patients with different genotypes | Baseline HDL-C of newly diagnosed with T2DM patients | 1 month of completion for individual screening | |
Secondary | Baseline LDL-C of newly diagnosed with T2DM patients with different genotypes | Baseline LDL-C of newly diagnosed with T2DM patients | 1 month of completion for individual screening | |
Secondary | Baseline BMI of controls with different genotypes | Baseline BMI of controls | 1 month of completion for individual screening | |
Secondary | Baseline WHR of controls with different genotypes | Baseline WHR of controls | 1 month of completion for individual screening | |
Secondary | Baseline FPG of controls with different genotypes | Baseline FPG of controls | 1 month of completion for individual screening | |
Secondary | Baseline HbA1c of controls with different genotypes | Baseline HbA1c of controls | 1 month of completion for individual screening | |
Secondary | Baseline TC of controls with different genotypes | Baseline TC of controls | 1 month of completion for individual screening | |
Secondary | Baseline TG of controls with different genotypes | Baseline TG of controls | 1 month of completion for individual screening | |
Secondary | Baseline HDL-C of controls with different genotypes | Baseline HDL-C of controls | 1 month of completion for individual screening | |
Secondary | Baseline LDL-C of controls with different genotypes | Baseline LDL-C of controls | 1 month of completion for individual screening |
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