Function of Beta Cells in Early-onset Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Medical Center Ho Chi Minh City (UMC)
About this trial
* 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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
A patient with type 2 diabetes mellitus presents for evaluation at the Endocrinology clinic of the University Medical Center of Ho Chi Minh City.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Monitor and observe the clinical progression and beta cell function
Other interventionMonitor and observe the clinical progression and beta cell function
Treatment groups
296 Participants
are divided into 2 treatment groupsGroup A: Early onset type 2 diabetes mellitus1 intervention
Group B: Type 2 diabetes mellitus typically presents1 intervention
Trial outcomes
Primary outcomes
1
Changes in fasting blood C-peptide concentration
Measurement of C-peptide concentration in venous blood (unit: nmol/L) using chemiluminescent immunoassay
Time frame
At baseline (T0), 6 months (T6), and 12 months (T12)2
Beta Cell Function Index (HOMA-B)
A mathematical model index (unit: %) is calculated based on fasting glucose and insulin/C-peptide concentrations. The formula is: HOMA-B = 20 x Fasting Insulin (µU/ml) / \[Fasting Glucose (mmol/L) - 3.5\]
Time frame
At baseline (T0), 6 months (T6), and 12 months (T12)Secondary outcomes
1
Insulin resistance status (HOMA-IR)
The index for assessing the level of insulin resistance in the body. The formula for calculation is: HOMA-IR = (Fasting Insulin (µU/ml) x Fasting Glucose (mmol/L)) / 22.5. A HOMA-IR value of ≥ 2.5 is considered indicative of insulin resistance.
Time frame
At baseline (T0), 6 months (T6), and 12 months (T12)2
The ability to regulate blood glucose levels through the HbA1C index
Measuring the percentage of glycosylated hemoglobin to assess average blood glucose levels over the past three months
Time frame
At regular intervals at time points T0, 3 months, 6 months, 9 months, and 12 months3
The incidence or progression of chronic complications
Assessment of the new onset or progression of major vascular complications (coronary artery disease, cerebrovascular disease, peripheral vascular disease) and microvascular complications (retinopathy, diabetic nephropathy, peripheral neuropathy)
Time frame
Record at time points T0, 6 months, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov