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Recruiting NCT06277466

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

No phase Interventional Type 2 Diabetes Mellitus Gene Polymorphisms Genetic Mutations Susceptibility, Genetic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugs, Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs.
Who it may be relevant to
Registry conditions: Type 2 Diabetes Mellitus, Gene Polymorphisms, Genetic Mutations, Susceptibility, Genetic. Basic parameters: 25 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University

Overview

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

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Detection of T2DM susceptibility gene expression in newly diagnosed T2DM patients [Time frame: 1 month after fresh sample collection]
  • Detection of T2DM susceptibility gene expression in controls [Time frame: 1 month after fresh sample collection]
  • Correlation between T2DM susceptibility gene expression and clinicopathological features [Time frame: 6 months after obtaining the clinicopathological results]
Secondary outcome measures (12)
  • Baseline BMI of newly diagnosed with T2DM patients with different genotypes [Time frame: 1 month of completion for individual screening]
  • Baseline waist hip ratio (WHR) of newly diagnosed with T2DM patients with different genotypes [Time frame: 1 month of completion for individual screening]
  • Baseline fasting plasma glucose (FPG) of newly diagnosed with T2DM patients with different genotypes [Time frame: 1 month of completion for individual screening]
  • Baseline HbA1c of newly diagnosed with T2DM patients with different genotypes [Time frame: 1 month of completion for individual screening]
  • Baseline TC of newly diagnosed with T2DM patients with different genotypes [Time frame: 1 month of completion for individual screening]
  • Baseline TG of newly diagnosed with T2DM patients with different genotypes [Time frame: 1 month of completion for individual screening]
  • Baseline HDL-C of newly diagnosed with T2DM patients with different genotypes [Time frame: 1 month of completion for individual screening]
  • Baseline LDL-C of newly diagnosed with T2DM patients with different genotypes [Time frame: 1 month of completion for individual screening]
  • Baseline BMI of controls with different genotypes [Time frame: 1 month of completion for individual screening]
  • Baseline WHR of controls with different genotypes [Time frame: 1 month of completion for individual screening]
  • Baseline FPG of controls with different genotypes [Time frame: 1 month of completion for individual screening]
  • Baseline HbA1c of controls with different genotypes [Time frame: 1 month of completion for individual screening]

Eligibility criteria

Inclusion criteria

  • 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）.
  • 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）.
  • 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

  • had taken antidiabetic drugs;
  • had a history of pancreatic surgery;
  • Complicated with severe organ lesions;
  • Long-term use of drugs that affect pancreatic function.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • China, Jiangsu, Department of Endocrinology — Xuzhou

Identifiers

NCT: NCT06277466 · XYFY2023-KL478-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗