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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06277466
Other study ID # XYFY2023-KL478-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date January 31, 2028

Study information

Verified date February 2024
Source The Affiliated Hospital of Xuzhou Medical University
Contact Tao Wang, Ph.D
Phone 13815344640
Email misswt2011@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugs
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 drugs
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.

Locations

Country Name City State
China China, Jiangsu, Department of Endocrinology Xuzhou

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

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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