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Function of Beta Cells in Early-onset Diabetes Mellitus

1. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

296

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Chi Khanh Hoang, Specialist physician level 1
  • Telefonnummer: 84985578494
  • E-mail: chi.hk@umc.edu.vn

Studiesteder

  • Vietnam
    • Cho Lon Ward
      • Ho Chi Minh City, Cho Lon Ward, Vietnam, 72700
        • Rekruttering
        • University of Medicine and Pharmacy of Ho Chi Minh City

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
Andet: 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
Andet: Monitor and observe the clinical progression and beta cell function
Monitor and observe the clinical progression and beta cell function

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in fasting blood C-peptide concentration
Tidsramme: 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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Insulin resistance status (HOMA-IR)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Medical Center Ho Chi Minh City (UMC)

Efterforskere

  • Ledende efterforsker: Chi Khanh Hoang, Specialist physician level 1, University of Medicine and Pharmacy of Ho Chi Minh City
  • Studieleder: Nam Quang Tran, Associate professor - Doctorat, University of Medicine and Pharmacy of Ho Chi Minh City
  • Studieleder: Tran Viet Thang, Doctorate, University of Medicine and Pharmacy of Ho Chi Minh City

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. februar 2025

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. februar 2028

Datoer for studieregistrering

Først indsendt

1. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. maj 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 7292/QĐ-ĐHYD

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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