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A Study of Blood Metabolic Markers in Patients With Type 2 Diabetes Mellitus of Different Stages

NCT ID: NCT06155539

Last Updated: 2023-12-04

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

NOT_YET_RECRUITING

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-31

Brief Summary

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Metabolomics is an emerging "omics" after genomics, transcriptomics and proteomics, which can reflect the physiological state of organisms more directly and accurately. Whether metabolite differences exist in patients with type 2 diabetes of different stages and whether such metabolite differences can be used as potential markers have not yet been studied, which is of great significance to explore. In this study, 105 patients with different stages of type 2 diabetes mellitus were enrolled according to the inclusion and exclusion criteria, and the metabolites in the samples were detected by ultra-high performance liquid chromatography coupled with tandem time-of-flight mass spectrometry (UHPLC-Q-TOF MS) after the blood samples were collected, and the corresponding investigative data were collected, and then baseline and demographic analyses, metabolomics data processing, and analysis of the results were carried out to provide a reference for the identification of metabolic markers and to provide a reference for the identification of significant metabolic markers in diabetic patients.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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Diabetes Mellitus Metabolic marker Metabolomics Stage of disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-diabetes

Fasting blood glucose level of 5.6-6.9 mmol/L (impaired fasting blood glucose) or 2-hour postprandial blood glucose of 7.8-11.0 mmol/L (impaired glucose tolerance) or haemoglobin A1c (HBA1c) of 5.7-6.4%.

No intervention

Intervention Type OTHER

No intervention

Diabetes in the early stages

Fasting blood glucose is higher than 7.0mmol/L, 2 hours postprandial blood glucose is higher than 11.1mmol/L, random blood glucose is higher than 11.1mmol/L with classic symptoms of hyperglycemia, and the HbA1C is higher than 6.5%, but there is no obvious complication of heart, kidney and eyes.

No intervention

Intervention Type OTHER

No intervention

Diabetes in the middle and late stages

Includes diabetics with various degrees of complications. Among the minor complications are microalbuminuria and mild diabetic retinopathy (e.g. microaneurysms, mild haemorrhages). Mild to moderate complications included diabetic nephropathy without renal failure and diabetic retinopathy without proliferative diabetic retinopathy. Severe complications include hyperglycaemic crises such as diabetic ketoacidosis and hyperosmolar hyperglycaemic state, microvascular complications such as retinopathy (neovascularisation and vitreous or preretinal haemorrhage preretinal haemorrhage), nephropathy, cardiomyopathy, neuropathy (sensory lesions such as podiatry, autonomic neuropathies such as sexual dysfunction and gastroparesis), and macrovascular complications (coronary heart disease, cerebrovascular disease, proliferative diabetic retinopathy, peripheral arterial disease, amputations and foot ulcers).

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 18 to 75 years old
2. Population of patients with type 2 diabetes mellitus of different stages
3. Subjects or legal representatives gave informed consent to voluntarily join the study by signing an informed consent form.

Exclusion Criteria

1. patients with severe acute underlying brain, cardiac, pulmonary, hepatic, renal and other conditions that the investigator believes to be influential
2. Patients diagnosed with any malignancy within the previous 5 years;
3. Received any form of oncological treatment including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy and immunotherapy prior to entry for blood sampling;
4. Organ transplant recipients or previous non-autologous (allogeneic) bone marrow or stem cell transplant recipients;
5. Those who have received blood transfusion therapy 1 month prior to the blood draw;
6. Patients with blood-borne diseases such as hepatitis, syphilis, and HIV;
7. Patients with other factors that, in the opinion of the investigator, influence the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peng Wu

OTHER

Sponsor Role lead

Responsible Party

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Peng Wu

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Peng Wu

Jinan, Shandong, China

Site Status

Countries

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China

Facility Contacts

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Peng Wu, Dr

Role: primary

Other Identifiers

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YXLL-KY-2023(132)

Identifier Type: -

Identifier Source: org_study_id