How beta cells work in early-onset type 2 diabetes

Comparison of Beta Cell Functional Changes in Patients With Early-onset Type 2 Diabetes Mellitus and Those With Typical Onset

This project will test whether beta cell function and HbA1C change differently over one year in Vietnamese adults with early-onset versus typical-onset type 2 diabetes.

Quick facts

• Study type: Observational
• Enrollment: 296 (estimated)
• Sex: All
• Sponsor: University Medical Center Ho Chi Minh City (UMC) (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Ho Chi Minh City, Cho Lon Ward)
• Trial ID: NCT07574138 on ClinicalTrials.gov

What this trial studies

This is a prospective cohort enrolling about 296 patients at the University Medical Center Ho Chi Minh City with follow-up visits at 3, 6, 9, and 12 months. Patients are grouped by age at diabetes onset (early-onset <40 years versus typical-onset ≥40 years) and must have T2DM diagnosed within the past 10 years and be off insulin for at least six months. Beta cell function and insulin resistance will be measured using HOMA-B, HOMA-IR, fasting C-peptide, and HbA1C, while clinical complications and paraclinical findings are recorded. The study compares trajectories of beta-cell function and glycemic control between groups over one year.

Who should consider this trial

Good fit: Adults with type 2 diabetes diagnosed within the past 10 years who are either early-onset (<40 years) or typical-onset (≥40 years), have been off insulin for at least six months, and (for early-onset) are negative for diabetes autoantibodies and willing to attend scheduled clinic visits.

Not a fit: People with type 1 diabetes or features suggesting type 1 diabetes, recent insulin dependence or diabetic ketoacidosis, pregnant women, or those unable to attend the Ho Chi Minh City clinic visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, results could help doctors identify faster beta-cell decline in younger patients and guide earlier or more tailored treatment strategies.

How similar studies have performed: Previous cohort studies have suggested earlier and more rapid beta-cell decline in younger-onset T2DM, but results have varied and clinical implications are not yet settled.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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).
* Severe renal failure with an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m².
* Use of medications that affect beta cell function or complications such as prolonged high-dose corticosteroids, immunosuppressive agents, or chemotherapy.
* Not of Vietnamese ethnicity.
* Non-compliance with treatment guidelines or failure to attend scheduled follow-up appointments.

Where this trial is running

Ho Chi Minh City, Cho Lon Ward

• University of Medicine and Pharmacy of Ho Chi Minh City — Ho Chi Minh City, Cho Lon Ward, Vietnam (RECRUITING)

Study contacts

• Principal investigator: Chi Khanh Hoang, Specialist physician level 1 — University of Medicine and Pharmacy of Ho Chi Minh City
• Study coordinator: Chi Khanh Hoang, Specialist physician level 1

Conditions: Type 2 Diabetes Mellitus, Beta Cell Function, Early-onset type 2 diabetes mellitus, Beta cell function, C-peptide