Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000, China
Location status: Recruiting
NCT Number: NCT06097065
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.
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Observational
Guangzhou, Guangdong, 510000, China
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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)).
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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Grouping based on detected oral glucose tolerance test results without any other intervention.
Time frame: one year
Obtain the number and types of proteins/peptides differential characteristic peaks between the case group and the control group through data analysis.
Time frame: one year
Construct a clinical predictive diagnostic model based on the obtained proteins/peptides differential feature peaks and calculate the area under the ROC curve AUC to evaluate the predictive effect of the model.
Contact information is provided by the study sponsor or research team.
Zhujiang Hospital
Other
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