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

NCT ID: NCT06277466

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2028-01-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus Gene Polymorphisms Genetic Mutations Susceptibility, Genetic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Comparison of T2DM susceptibility gene expression between newly diagnosed T2DM patients and controls

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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China, Jiangsu, Department of Endocrinology

Xuzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tao Wang, Ph.D

Role: CONTACT

13815344640

Xiaoxing Yin, Ph.D

Role: CONTACT

13605218523

Facility Contacts

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Hongwei Ling, MD

Role: primary

18052268607

Other Identifiers

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XYFY2023-KL478-01

Identifier Type: -

Identifier Source: org_study_id

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