RecruitingNCT07574138

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

Sponsor

University Medical Center Ho Chi Minh City (UMC)

Enrollment

296 participants

Start Date

Feb 24, 2025

Study Type

OBSERVATIONAL

Conditions

Type 2 Diabetes Mellitus (T2DM)Beta Cell Function

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

Inclusion Criteria6

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 Criteria7

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.