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

November 24, 2023 updated by: Peng Wu
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250014
        • Peng Wu
        • Contact:
        • Principal Investigator:
          • Peng Wu, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differential metabolites
Time Frame: 2024.01-2025.12
2024.01-2025.12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peng Wu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 24, 2023

First Submitted That Met QC Criteria

November 24, 2023

First Posted (Estimated)

December 4, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YXLL-KY-2023(132)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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