Actively Recruiting
Function of Beta Cells in Early-onset Diabetes Mellitus
Led by University Medical Center Ho Chi Minh City (UMC) · Updated on 2026-05-07
296
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
* Research objectives: Evaluate and compare the clinical and paraclinical characteristics, complications, as well as the changes in beta cell function and HbA1C levels between two patient groups over a one-year follow-up period. +Research design: This is a prospective cohort study, monitoring patients at 3, 6, 9, and 12 months. * Study Population and Sample Size: The study is planned to be conducted on 296 Vietnamese patients (accounting for a 20% dropout rate) who are being examined at the University of Medicine and Pharmacy Hospital in Ho Chi Minh City. * Key Evaluation Indicators: The function of beta cells and insulin resistance status are measured through the indices of HOMA-B, HOMA-IR, fasting C-peptide levels, and HbA1C levels. * Time and location: The study will be conducted from February 2025 to February 2028 at the Endocrinology Clinic, University Medical Center Ho Chi Minh City.
CONDITIONS
Official Title
Function of Beta Cells in Early-onset Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Type 2 Diabetes Mellitus according to ADA 2024 criteria
- Duration of Type 2 Diabetes Mellitus 10 years or less
- Classified as early onset (under 40 years) or typical onset (40 years and above)
- At least 6 months without insulin treatment and no diabetic ketoacidosis episodes since diagnosis
- Early-onset group must have negative autoantibodies (Anti-GAD, ICA) and fasting C-peptide levels above 0.6 nmol/L
- Patient agrees to participate and signs informed consent
You will not qualify if you...
- Pregnant women or patients with acute illness at assessment
- Diagnosed with or suspected Type 1 Diabetes Mellitus (history of ketoacidosis, C-peptide below 0.2 nmol/L)
- Secondary diabetes from pancreatic disorders, medications, or endocrine diseases
- Severe kidney failure with eGFR below 30 mL/min/1.73 m2
- Use of medications affecting beta cell function or complications (high-dose corticosteroids, immunosuppressants, chemotherapy)
- Not of Vietnamese ethnicity
- Non-compliance with treatment or missed follow-up appointments
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Medicine and Pharmacy of Ho Chi Minh City
Ho Chi Minh City, Cho Lon Ward, Vietnam, 72700
Actively Recruiting
Research Team
C
Chi Khanh Hoang, Specialist physician level 1
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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