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Clinical trial Recruiting at 1 site Observational

How beta cells work in early-onset type 2 diabetes

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

Run by University Medical Center Ho Chi Minh City (UMC) · NCT07574138 · Data updated 2026-11-12

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 typeObservational
SexAll
Enrollment296 (estimated)
SponsorUniversity Medical Center Ho Chi Minh City (UMC)
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Ho Chi Minh City, Cho Lon Ward)
StatusRecruiting
StartedFebruary 24, 2025
Main results expectedDecember 2027
Study endsFebruary 2028
Registry record updatedMay 7, 2026
Trial IDNCT07574138 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
  • Email: chi.hk@umc.edu.vn
  • Phone: 84985578494

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Type 2 Diabetes Mellitus (T2DM) 68University Medical Center Ho Chi Minh City (UMC) 14
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.