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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorThe Affiliated Hospital of Xuzhou Medical University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

had taken antidiabetic drugs;

had a history of pancreatic surgery;

Complicated with severe organ lesions;

Long-term use of drugs that affect pancreatic function.

Trial design

Design model

Single group

Treatments tested in this trial

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

    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

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Comparison of T2DM susceptibility gene expression between newly diagnosed T2DM patients and controlsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month after fresh sample collection
2

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.

Time frame
1 month after fresh sample collection
3

Correlation between T2DM susceptibility gene expression and clinicopathological features

Incidence of clinical pancreatic diseases under expression differences in T2DM susceptibility genes

Time frame
6 months after obtaining the clinicopathological results

Secondary outcomes

1

Baseline BMI of newly diagnosed with T2DM patients with different genotypes

Baseline BMI of newly diagnosed with T2DM patients

Time frame
1 month of completion for individual screening
2

Baseline waist hip ratio (WHR) of newly diagnosed with T2DM patients with different genotypes

Baseline WHR of newly diagnosed with T2DM patients

Time frame
1 month of completion for individual screening
3

Baseline fasting plasma glucose (FPG) of newly diagnosed with T2DM patients with different genotypes

Baseline FPG of newly diagnosed with T2DM patients

Time frame
1 month of completion for individual screening
4

Baseline HbA1c of newly diagnosed with T2DM patients with different genotypes

Baseline HbA1c of newly diagnosed with T2DM patients

Time frame
1 month of completion for individual screening

Other outcomes

Sponsors and contacts

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