Research on Potential Biomarkers of Prediabetes and Diabetes Based on MALDI-TOF MS Platform.
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: Oral Glucose Tolerance Test.
- Who it may be relevant to
- Registry conditions: Prediabetes, Diabetes Mellitus, Gestational Diabetes Mellitus, Proteomics. Basic parameters: No limits · 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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Overview
Through the MALDI-TOF MS platform, explore the proteomics and peptidomics differences of fasting serum/plasma and urine between non pregnant people with normal glucose tolerance test and prediabetes /diabetes patients, pregnant people with normal glucose tolerance test and pregnant diabetes patients respectively; To explore the role of its proteomics and peptidomics differences in the diagnosis of prediabetes and diabetes, and to establish a new method of differential diagnosis by using the omics data and key characteristic peaks to find potential new diagnostic markers.
Detailed description
Prediabetes is a stage of abnormal glucose metabolism between normal blood glucose level and diabetes, which is a "gray zone" between normal and abnormal, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both. It is a very important high-risk group of diabetes. Diabetes is a group of metabolic diseases characterized by hyperglycemia caused by a variety of causes. Gestational diabetes mellitus refers to varying degrees of abnormal glucose metabolism that occur during pregnancy. This project aims to detect differential feature peaks through MALDI-TOF MS technology between non pregnant people with normal glucose tolerance test and prediabetes/diabetes patients, pregnant people with normal glucose tolerance test and pregnant diabetes patients respectively and to establish a clinical predictive diagnostic model based on differences, and to evaluate the model.
Interventions
- Diagnostic test Oral Glucose Tolerance Test
Grouping based on detected oral glucose tolerance test results without any other intervention.
Primary outcome measures
- Number and types of proteins/peptides differential characteristic peaks [Time frame: one year]
Secondary outcome measures (1)
- ROC curve and area under curve AUC of clinical predictive diagnostic model [Time frame: one year]
Eligibility criteria
Inclusion criteria
- Inclusion criteria for cases:
Non pregnant people: the remaining fasting serum/plasma and urine samples of prediabetes/diabetes patients (prediabetes: IFG: FPG 6.1-6.9mmol/L, Blood glucose 2h after meal<7.8mmol/L（WHO）; IGT: FPG<7.0mmol/L, Blood glucose 2h after meal 7.8-11.1mmol/L（WHO）; diabetes: Typical symptoms of diabetes, FPG >= 7.0mmol/L or 75g OGTT 2h blood glucose >= 11.1mmol/L).
Pregnant people: the remaining fasting serum/plasma and urine samples of gestational diabetes patients (75g OGTT test FPG >= 5.1mmol/L or 1h blood glucose >= 10.0mmol/L or 2h blood glucose >= 8.5mmol/L（IADPSG; ADA)).
- Inclusion criteria of the controls were as follows:
Non pregnant people: the remaining fasting serum/plasma and urine samples of normal population for glucose tolerance test (FPG 3.9-6.1mmol/L,75g OGTT test 1h blood glucose 6.7-11.1mmol/L,75g OGTT test 2h blood glucose 3.6-7.8mmol/L).
Pregnant people: the remaining fasting serum/plasma and urine samples of people who do not meet the diagnostic criteria for gestational diabetes (3.9<=75g OGTT test FPG<5.1mmol/L,6.7 <= 1h blood glucose<10.0mmol/L,3.6<=2h blood glucose<8.5mmol/L).
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Exclusion criteria
Common exclusion criteria for cases and control were as follows: The sample volume of serum/plasma/urine is less than 300ul; Improper storage of samples or repeated freezing and thawing; The serum /plasma has obvious hemolysis, lipemia or jaundice.
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Zhujiang Hospital of Southern Medical University — Guangzhou
Identifiers
NCT: NCT06097065 · Zhujiangzx