Effect of Mutations in T2DM Susceptibility Genes on the Expression of Susceptibility Genes in Patients With T2DM and Controls

NCT06277466 · tracked via the Priya Life Science China tracker

Sponsor

The Affiliated Hospital of Xuzhou Medical University

Phase

Not applicable

Started

2024-01-01

Last updated

2024-02-28

Condition(s) studied

Type 2 Diabetes MellitusGene PolymorphismsGenetic MutationsSusceptibility, Genetic

Investigational drug(s) / intervention(s)

Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugsFresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs

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.

Study 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.

Eligibility

Sex

ALL

Min age

25 Years

Max age

70 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Detection of T2DM susceptibility gene expression in newly diagnosed T2DM patients — 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 — 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 — 6 months after obtaining the clinicopathological results
Incidence of clinical pancreatic diseases under expression differences in T2DM susceptibility genes

Trial sites (1)

Facility	City	Region	Status
China, Jiangsu, Department of Endocrinology	Xuzhou	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06277466 on ClinicalTrials.gov ↗ ← All trials in China