Type 2 Diabetes Mellitus (T2DM)NCT07574138
Function of Beta Cells in Early-onset Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus (T2DM) and Beta Cell Function, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Beta Cell Function
- What is being tested?
- Monitor and observe the clinical progression and beta cell function
- How many people
- 296 participants
- Where
- 1 siteVietnam
- Study dates
- 24 Feb 2025to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
University of Medicine and Pharmacy of Ho Chi Minh City
Ho Chi Minh City, Cho Lon Ward, 72700
About this study
Official title: Comparison of Beta Cell Functional Changes in Patients With Early-onset Type 2 Diabetes Mellitus and Those With Typical Onset
- 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.
Read the detailed description
- Research Objectives
- Objective 1: Comparison of clinical characteristics, paraclinical findings, and complications in two groups of patients with early-onset and typical-onset Type 2 Diabetes Mellitus at the University of Medicine and Pharmacy Hospital in Ho Chi Minh City.
- Objective 2: Comparison of changes in beta cell function and related factors in patients with early-onset and typical-onset Type 2 Diabetes Mellitus during a one-year follow-up at the University of Medicine and Pharmacy in Ho Chi Minh City.
- Objective 3: Comparison of HbA1C levels and related factors in patients with early-onset and typical-onset Type 2 Diabetes Mellitus during a one-year follow-up at the University of Medicine and Pharmacy Hospital in Ho Chi Minh City.
- Study Population and Research Methods
- Research design: Prospective observational cohort study.
- Time and location: Implementation from February 2025 to February 2028 at the Endocrinology Clinic - University Medical Center Ho Chi Minh City.
- Sample size: A minimum of 246 patients is required (equally divided into 2 groups). To account for a 20% dropout rate, the study plans to initially enroll 296 patients.
- Sampling criteria:
- Early Onset Group:
- Patient with early-onset Type 2 Diabetes Mellitus (onset age ≥ 40 years).
- Duration of Type 2 Diabetes Mellitus diagnosis 10 years.
- Common onset group: Diagnosed with Type 2 Diabetes Mellitus from the age of 40 and above.
- Patient with type 2 diabetes mellitus typically onset (onset age ≥ 40 years).
- Duration of Type 2 Diabetes Mellitus 10 years.
- To control for confounding factors, the study employed a 1:1 matching based on disease duration ( 1 year, 1-5 years, 5- 10 years).
- Exclusion criteria: Excluding cases of type 1 diabetes (based on antibodies and C-peptide), secondary diabetes (due to medication, pancreatic pathology, etc.), pregnant women, or patients with severe renal impairment (eGFR < 30).
- Data Collection Process and Research Variables
- The patient was monitored over a 12-month period with assessment milestones at T0 (baseline), T3, T6, T9, and T12.
- Clinical variables: Age, sex, BMI, waist-to-hip ratio, blood pressure, family history, smoking/alcohol consumption habits.
- Complication variables: Coronary artery disease, cerebrovascular disease, peripheral artery disease, retinopathy, and renal parameters (urinary albumin, eGFR).
- Treatment variables: Oral medication regimen (Metformin, Sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors...), dosage and insulin regimen.
- Clinical variables: HbA1C, beta cell function (fasting C-peptide, HOMA-B, HOMA-IR).
- Data analysis methods
- The study utilized R version 4.1.2 software for data analysis.
- Utilize t-tests, ANOVA, or Wilcoxon tests to compare means among groups.
- The study applies the Bayesian Model Average (BMA) multivariate linear regression model to identify the optimal models for predicting the decline in beta cell function, HbA1C levels, and the exclusion of confounding factors.
- Ethics and Security
- The patient participates voluntarily and has signed the Informed Consent Form for participation in the study.
- All personal information is encrypted and kept completely confidential, utilized solely for scientific purposes.
- Approval from the Ethics Committee in Biomedical Research of the University of Medicine and Pharmacy in Ho Chi Minh City, number 936/ĐHYD-HĐĐĐ, dated February 24, 2025.
- Being tested
- Monitor and observe the clinical progression and beta cell function
- Keywords
- Early-onset type 2 diabetes mellitus, Beta cell function, C-peptide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitor and observe the clinical progression and beta cell functionOther
Monitor and observe the clinical progression and beta cell function
| Study group | Role | What they receive |
|---|---|---|
| Early onset type 2 diabetes mellitus | Includes patients diagnosed with type 2 diabetes mellitus according to the ADA 2024 criteria with an onset age of under 40 years Receives: Other: Monitor and observe the clinical progression and beta cell function | |
| Type 2 diabetes mellitus typically presents | Includes patients diagnosed with type 2 diabetes mellitus according to the ADA 2024 criteria, with an onset age of 40 years or older Receives: Other: Monitor and observe the clinical progression and beta cell function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fasting blood C-peptide concentration
Measurement of C-peptide concentration in venous blood (unit: nmol/L) using chemiluminescent immunoassay
Measured: At baseline (T0), 6 months (T6), and 12 months (T12)
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]
Measured: At baseline (T0), 6 months (T6), and 12 months (T12)
Secondary outcomes (3)
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.
Measured: At baseline (T0), 6 months (T6), and 12 months (T12)
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
Measured: At regular intervals at time points T0, 3 months, 6 months, 9 months, and 12 months
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)
Measured: Record at time points T0, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start24 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi Khanh Hoang, Specialist physician level 1, Principal investigator, University of Medicine and Pharmacy of Ho Chi Minh CityNam Quang Tran, Associate professor - Doctorat, Study director, University of Medicine and Pharmacy of Ho Chi Minh CityTran Viet Thang, Doctorate, Study director, University of Medicine and Pharmacy of Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574138
- Sponsor's protocol ID
- 7292/QĐ-ĐHYD
- Status last verified
- Apr 2026
- First submitted
- 1 May 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Beta Cell Functional Changes in Patients With Early-onset Type 2 Diabetes Mellitus and Those With Typical Onset
- ClinicalTrials.gov ID
- NCT07574138
- Acronym / sponsor ID
- 7292/QĐ-ĐHYD
- Keywords
- Early-onset type 2 diabetes mellitus, Beta cell function, C-peptide
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed description
- Research Objectives
- Objective 1: Comparison of clinical characteristics, paraclinical findings, and complications in two groups of patients with early-onset and typical-onset Type 2 Diabetes Mellitus at the University of Medicine and Pharmacy Hospital in Ho Chi Minh City.
- Objective 2: Comparison of changes in beta cell function and related factors in patients with early-onset and typical-onset Type 2 Diabetes Mellitus during a one-year follow-up at the University of Medicine and Pharmacy in Ho Chi Minh City.
- Objective 3: Comparison of HbA1C levels and related factors in patients with early-onset and typical-onset Type 2 Diabetes Mellitus during a one-year follow-up at the University of Medicine and Pharmacy Hospital in Ho Chi Minh City.
- Study Population and Research Methods
- Research design: Prospective observational cohort study.
- Time and location: Implementation from February 2025 to February 2028 at the Endocrinology Clinic - University Medical Center Ho Chi Minh City.
- Sample size: A minimum of 246 patients is required (equally divided into 2 groups). To account for a 20% dropout rate, the study plans to initially enroll 296 patients.
- Sampling criteria:
- Early Onset Group:
- Patient with early-onset Type 2 Diabetes Mellitus (onset age ≥ 40 years).
- Duration of Type 2 Diabetes Mellitus diagnosis 10 years.
- Common onset group: Diagnosed with Type 2 Diabetes Mellitus from the age of 40 and above.
- Patient with type 2 diabetes mellitus typically onset (onset age ≥ 40 years).
- Duration of Type 2 Diabetes Mellitus 10 years.
- To control for confounding factors, the study employed a 1:1 matching based on disease duration ( 1 year, 1-5 years, 5- 10 years).
- Exclusion criteria: Excluding cases of type 1 diabetes (based on antibodies and C-peptide), secondary diabetes (due to medication, pancreatic pathology, etc.), pregnant women, or patients with severe renal impairment (eGFR < 30).
- Data Collection Process and Research Variables
- The patient was monitored over a 12-month period with assessment milestones at T0 (baseline), T3, T6, T9, and T12.
- Clinical variables: Age, sex, BMI, waist-to-hip ratio, blood pressure, family history, smoking/alcohol consumption habits.
- Complication variables: Coronary artery disease, cerebrovascular disease, peripheral artery disease, retinopathy, and renal parameters (urinary albumin, eGFR).
- Treatment variables: Oral medication regimen (Metformin, Sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors...), dosage and insulin regimen.
- Clinical variables: HbA1C, beta cell function (fasting C-peptide, HOMA-B, HOMA-IR).
- Data analysis methods
- The study utilized R version 4.1.2 software for data analysis.
- Utilize t-tests, ANOVA, or Wilcoxon tests to compare means among groups.
- The study applies the Bayesian Model Average (BMA) multivariate linear regression model to identify the optimal models for predicting the decline in beta cell function, HbA1C levels, and the exclusion of confounding factors.
- Ethics and Security
- The patient participates voluntarily and has signed the Informed Consent Form for participation in the study.
- All personal information is encrypted and kept completely confidential, utilized solely for scientific purposes.
- Approval from the Ethics Committee in Biomedical Research of the University of Medicine and Pharmacy in Ho Chi Minh City, number 936/ĐHYD-HĐĐĐ, dated February 24, 2025.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early onset type 2 diabetes mellitus | – | Other: Monitor and observe the clinical progression and beta cell functionIncludes patients diagnosed with type 2 diabetes mellitus according to the ADA 2024 criteria with an onset age of under 40 years |
| Type 2 diabetes mellitus typically presents | – | Other: Monitor and observe the clinical progression and beta cell functionIncludes patients diagnosed with type 2 diabetes mellitus according to the ADA 2024 criteria, with an onset age of 40 years or older |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitor and observe the clinical progression and beta cell functionMonitor and observe the clinical progression and beta cell function | Other | Early onset type 2 diabetes mellitus, Type 2 diabetes mellitus typically presents |
Primary outcome
Changes in fasting blood C-peptide concentration
Time frame: At baseline (T0), 6 months (T6), and 12 months (T12)
Measurement of C-peptide concentration in venous blood (unit: nmol/L) using chemiluminescent immunoassay
Beta Cell Function Index (HOMA-B)
Time frame: At baseline (T0), 6 months (T6), and 12 months (T12)
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]
3 secondary outcomes
Insulin resistance status (HOMA-IR)
Time frame: At baseline (T0), 6 months (T6), and 12 months (T12)
The ability to regulate blood glucose levels through the HbA1C index
Time frame: At regular intervals at time points T0, 3 months, 6 months, 9 months, and 12 months
The incidence or progression of chronic complications
Time frame: Record at time points T0, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi Khanh Hoang, Specialist physician level 1 principal investigator
University of Medicine and Pharmacy of Ho Chi Minh City
Nam Quang Tran, Associate professor - Doctorat study director
University of Medicine and Pharmacy of Ho Chi Minh City
Tran Viet Thang, Doctorate study director
University of Medicine and Pharmacy of Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and Beta Cell Function, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi Khanh Hoang, Specialist physician level 1 (84985578494, chi.hk@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fasting blood C-peptide concentration (time frame: At baseline (T0), 6 months (T6), and 12 months (T12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.