Type 2 diabetes mellitus and prediabetes are major public health problems worldwide and in Thailand. The prevalence of diabetes among Thai adults has increased substantially over the past decades. Many individuals remain undiagnosed because hyperglycemia may be asymptomatic in early stages. Delayed diagnosis often leads to the development of chronic complications such as cardiovascular disease, chronic kidney disease, neuropathy, and diabetic retinopathy. Therefore, early detection of abnormal g
Conditions
Interventions
75-g oral glucose tolerance test (OGTT), which serves as the reference standard for the diagnosis of type 2 diabetes mellitus. Plasma glucose levels will be measured in accordance with standard clinic
Active Comparator Drug
75g OGTT
Sponsors
EC Siriraj
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age since 18 years. 2. Diagnosed with prediabetes according to the American Diabetes Association (ADA) criteria, based on the most recent follow-up laboratory results, meeting at least one of the following criteria
Exclusion criteria
Exclusion criteria: 1. Previous diagnosis of diabetes mellitus or current use of any glucose-lowering medications. 2. Pregnancy or breastfeeding, or planning to become pregnant during the study period. 3. Inability to undergo the oral glucose tolerance test (OGTT) according to the study protocol. 4. History of gastrointestinal surgery that may affect glucose absorption (e.g., gastric bypass, gastrectomy, or short bowel syndrome). 5. Acute illness or acute infection within 2 weeks prior to testing, or recent hospitalization due to an emergency condition. 6. Use of medications that significantly affect glucose metabolism within the past 4 weeks 7. Use of medications affecting blood glucose. 8.Severe chronic kidney diseaseor severe liver disease 9. Anemia or red blood cell disorders that may affect HbA1c measurement or interpretation 10. Uncontrolled endocrine disorders with a significant impact on glucose metabolism 11.Heart failure or unstable cardiovascular disease within the past 3 months 12. Active psychiatric disorders or substance abuse that may impair the ability to provide informed 13. consent or comply with the study protocol. 14. Participation in another clinical trial that may interfere with the assessment of study outcomes. 15. Unwillingness to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of the 50-g glucose challenge test (GCT) for detection of type 2 diabetes mellitus 2-3weeks Sensitivity, specificity, PPV, NPV, and AUC of the 50-g GCT compared with the 75-g OGTT as the reference standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of the 50-g glucose challenge test (GCT) for detection of type 2 diabetes mellitus, using the 75-g oral glucose tolerance test (OGTT) as the reference standard. 3weeks Blood samples will be analyzed using standardized laboratory methods at the study site. | — |
Countries
Thailand
Contacts
Public ContactSansanee Chotejaroensin
Siriraj hospital
Outcome results
None listed