NCT07574138Recruiting
Function of Beta Cells in Early-onset Diabetes Mellitus
Comparison of Beta Cell Functional Changes in Patients With Early-onset Type 2 Diabetes Mellitus and Those With Typical Onset
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
* 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 296 (estimated)
- First submitted
- 1 May 2026
- Start date
- 24 Feb 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Diseases
- Type 2 diabetes
- NCT number
- NCT07574138
What you commit to
- Study type: Observational
- Planned participants: 296
- From 24 Feb 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of medications that affect beta cell function or complications such as prolonged high-dose corticosteroids, immunosuppressive agents, or chemotherapy.
Other illness
- 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.
Lab values
- Severe renal failure with an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m².
Other
- Not of Vietnamese ethnicity.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Medicine and Pharmacy of Ho Chi Minh City Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.