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Function of Beta Cells in Early-onset Diabetes Mellitus

2026년 5월 1일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

  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.

연구 유형

관찰

등록 (추정된)

296

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Chi Khanh Hoang, Specialist physician level 1
  • 전화번호: 84985578494
  • 이메일: chi.hk@umc.edu.vn

연구 장소

  • 베트남
    • Cho Lon Ward
      • Ho Chi Minh City, Cho Lon Ward, 베트남, 72700
        • 모병
        • University of Medicine and Pharmacy of Ho Chi Minh City

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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
다른: 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
다른: Monitor and observe the clinical progression and beta cell function
Monitor and observe the clinical progression and beta cell function

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Changes in fasting blood C-peptide concentration
기간: 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)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Insulin resistance status (HOMA-IR)
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Medical Center Ho Chi Minh City (UMC)

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 2월 24일

기본 완료 (추정된)

2027년 12월 1일

연구 완료 (추정된)

2028년 2월 1일

연구 등록 날짜

최초 제출

2026년 5월 1일

QC 기준을 충족하는 최초 제출

2026년 5월 1일

처음 게시됨 (실제)

2026년 5월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 1일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 7292/QĐ-ĐHYD

개별 참가자 데이터(IPD) 계획

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아니요

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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