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Function of Beta Cells in Early-onset Diabetes Mellitus

1 mai 2026 mis à jour par: University Medical Center Ho Chi Minh City (UMC)

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.

Type d'étude

Observationnel

Inscription (Estimé)

296

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Chi Khanh Hoang, Specialist physician level 1
  • Numéro de téléphone: 84985578494
  • E-mail: chi.hk@umc.edu.vn

Lieux d'étude

  • Viêt Nam
    • Cho Lon Ward
      • Ho Chi Minh City, Cho Lon Ward, Viêt Nam, 72700
        • Recrutement
        • University of Medicine and Pharmacy of Ho Chi Minh City

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

A patient with type 2 diabetes mellitus presents for evaluation at the Endocrinology clinic of the University Medical Center of Ho Chi Minh City.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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
Autre: Monitor and observe the clinical progression and beta cell function
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
Autre: Monitor and observe the clinical progression and beta cell function
Monitor and observe the clinical progression and beta cell function

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Changes in fasting blood C-peptide concentration
Délai: At baseline (T0), 6 months (T6), and 12 months (T12)
Measurement of C-peptide concentration in venous blood (unit: nmol/L) using chemiluminescent immunoassay
At baseline (T0), 6 months (T6), and 12 months (T12)
Beta Cell Function Index (HOMA-B)
Délai: 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]
At baseline (T0), 6 months (T6), and 12 months (T12)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Insulin resistance status (HOMA-IR)
Délai: At baseline (T0), 6 months (T6), and 12 months (T12)
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.
At baseline (T0), 6 months (T6), and 12 months (T12)
The ability to regulate blood glucose levels through the HbA1C index
Délai: At regular intervals at time points T0, 3 months, 6 months, 9 months, and 12 months
Measuring the percentage of glycosylated hemoglobin to assess average blood glucose levels over the past three months
At regular intervals at time points T0, 3 months, 6 months, 9 months, and 12 months
The incidence or progression of chronic complications
Délai: Record at time points T0, 6 months, and 12 months
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)
Record at time points T0, 6 months, and 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Medical Center Ho Chi Minh City (UMC)

Les enquêteurs

  • Chercheur principal: Chi Khanh Hoang, Specialist physician level 1, University of Medicine and Pharmacy of Ho Chi Minh City
  • Directeur d'études: Nam Quang Tran, Associate professor - Doctorat, University of Medicine and Pharmacy of Ho Chi Minh City
  • Directeur d'études: Tran Viet Thang, Doctorate, University of Medicine and Pharmacy of Ho Chi Minh City

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

24 février 2025

Achèvement primaire (Estimé)

1 décembre 2027

Achèvement de l'étude (Estimé)

1 février 2028

Dates d'inscription aux études

Première soumission

1 mai 2026

Première soumission répondant aux critères de contrôle qualité

1 mai 2026

Première publication (Réel)

7 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 mai 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 7292/QĐ-ĐHYD

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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