NCT07574138 Function of Beta Cells in Early-onset Diabetes Mellitus

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 296 participants in total. It began in 2025-02-24 with a primary completion date of 2027-12.

Brief Summary

* 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.

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.

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