Function of Beta Cells in Early-onset Diabetes Mellitus
Recruiting · NCT07574138 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
1 location listed.
- University of Medicine and Pharmacy of Ho Chi Minh City - Ho Chi Minh City, Cho Lon Ward, Vietnam