Function of Beta Cells in Early-onset Diabetes Mellitus

Recruiting now

Conditions studied: Type 2 Diabetes Mellitus (T2DM), Beta Cell Function

In brief

* 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.

Key facts

Study ID

NCT07574138

Run by

University Medical Center Ho Chi Minh City (UMC)

People needed

296

Starts

2025-02-24

Expected to finish

2028-02-01

Last updated by the study team

2026-05-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

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

Full record on ClinicalTrials.gov

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