Comparing Insulin-Producing Cell Function in Early-Onset and Typical-Onset Type 2 Diabetes
Follows people with type 2 diabetes for one year, comparing early and typical onset.
Plain-language title generated from the registry record
Registry title: Function of Beta Cells in Early-onset Diabetes Mellitus
Key facts
- Where
- Ho Chi Minh City, VietnamSee the site
Where in Vietnam
- University of Medicine and Pharmacy of Ho Chi Minh CityHo Chi Minh City, VietnamTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Center Ho Chi Minh City (UMC)
- Trial code
- NCT07574138
- Record updated
- 7 May 2026
- Original description
* 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.Read full original descriptionShow less
Comparison of Beta Cell Functional Changes in Patients With Early-onset Type 2 Diabetes Mellitus and Those With Typical Onset
* 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.
Inclusion: The patient is diagnosed with Type 2 Diabetes Mellitus according to the ADA 2024 criteria (Fasting Glucose ≥ 126 mg/dl, or Glucose after 2 hours of an Oral Glucose Tolerance Test ≥ 200 mg/dl, or HbA1C ≥ 6.5%, or with typical symptoms accompanied by any Glucose ≥ 200 mg/dl); The duration of Type 2 Diabetes Mellitus does not exceed 10 years; Classification by age of onset: Early onset group (< 40 years) and typical onset group (≥ 40 years); At least 6 months without the need for insulin and no recorded episodes of diabetic ketoacidosis since the time of diagnosis; For the early-onset group: Autoantibodies (Anti-GAD, ICA) are negative and fasting C-peptide levels are > 0.6 nmol/L; The patient consents to participate in the study and signs the informed consent document.
Exclusion: Use of medications that affect beta cell function or complications such as prolonged high-dose corticosteroids, immunosuppressive agents, or chemotherapy; Pregnant women or patients with acute illnesses at the time of assessment; The patient has been diagnosed with or exhibits characteristics suggestive of Type 1 Diabetes Mellitus (such as a history of ketoacidosis, C-peptide < 0.2 nmol/L); Secondary diabetes mellitus due to pancreatic disorders (pancreatitis, pancreatic tumors, pancreatic resection), due to medications (glucocorticoids), or due to other endocrine disorders (Cushing's syndrome, hyperthyroidism, acromegaly); Non-compliance with treatment guidelines or failure to attend scheduled follow-up appointments; Severe renal failure with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²; Not of Vietnamese ethnicity.