Research on Potential Biomarkers of Prediabetes and Diabetes Based on MALDI-TOF MS Platform.

NCT06097065 | Recruiting

• 1 other identifier: Zhujiangzx
• Study Type: observational
• Target: 2,860
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prediabetes; Diabetes Mellitus; Gestational Diabetes Mellitus; Proteomics

Outcome Measures

Primary Outcomes (1)

• Number and types of proteins/peptides differential characteristic peaks

  Obtain the number and types of proteins/peptides differential characteristic peaks between the case group and the control group through data analysis.

  one year

Secondary Outcomes (1)

• ROC curve and area under curve AUC of clinical predictive diagnostic model

  one year

Study Arms (4)

Non pregnant people with prediabetes or diabetes

Non pregnancy meeting the diagnosis of prediabetes or diabetes.

Diagnostic Test: Oral Glucose Tolerance Test

Non pregnant people with normal glucose tolerance

Non pregnant population with normal Oral Glucose Tolerance Test results.

Diagnostic Test: Oral Glucose Tolerance Test

pregnant people with gestational diabetes mellitus

Pregnant people who meet the diagnosis of gestational diabetes.

Diagnostic Test: Oral Glucose Tolerance Test

pregnant people with normal glucose tolerance

Pregnant people with normal Oral Glucose Tolerance Test results.

Diagnostic Test: Oral Glucose Tolerance Test

Interventions

Oral Glucose Tolerance Test DIAGNOSTIC_TEST

Grouping based on detected oral glucose tolerance test results without any other intervention.

Non pregnant people with normal glucose tolerance; Non pregnant people with prediabetes or diabetes; pregnant people with gestational diabetes mellitus; pregnant people with normal glucose tolerance

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

(1) cases: Non pregnant people: the remaining fasting serum/plasma and urine samples of prediabetes/diabetes patients; Pregnant people: the remaining fasting serum/plasma and urine samples of gestational diabetes patients. (2) controls: (Non)pregnant people: the remaining fasting serum/plasma and urine samples of normal population.

You may qualify if:

• 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).

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus; Diabetes, Gestational

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Hongwei Zhou, Professor

  Zhujiang Hospital

  STUDY CHAIR

Central Study Contacts

Nianyi Zeng

CONTACT

13928801657; zengny1@i.smu.edu.cn

Hongwei Zhou, Professor

CONTACT

18688489622; hzhou@smu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 24, 2023
• Study Start: May 20, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 24, 2023

Record last verified: 2023-02

Locations

CN (1)