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

NCT06155539 | Unknown DMC

• 1 other identifier: YXLL-KY-2023(132)
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus; Metabolic marker; Metabolomics; Stage of disease

Outcome Measures

Primary Outcomes (1)

• Differential metabolites

  2024.01-2025.12

Study Arms (3)

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%.

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.

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).

Other: No intervention

Interventions

No intervention OTHER

No intervention

Diabetes in the early stages; Diabetes in the middle and late stages; Pre-diabetes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Blood samples were collected from type 2 diabetic patients with different stages of diabetes mellitus (pre-stage, early-stage, and mid-late-stage), 35 cases in each stage, 105 cases in total

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peng Wu: lead

Study Sites (1)

Peng Wu

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: January 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

CN (1)