Function of Beta Cells in Early-onset Diabetes Mellitus
2026年5月1日 更新者：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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
観察的
入学 (推定)
296
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Chi Khanh Hoang, Specialist physician level 1
- 電話番号：84985578494
- メール：chi.hk@umc.edu.vn
研究場所
-
-
Cho Lon Ward
-
Ho Chi Minh City、Cho Lon Ward、ベトナム、72700
- 募集
- University of Medicine and Pharmacy of Ho Chi Minh City
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
A patient with type 2 diabetes mellitus presents for evaluation at the Endocrinology clinic of the University Medical Center of Ho Chi Minh City.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
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
|
Monitor and observe the clinical progression and beta cell function
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in fasting blood C-peptide concentration
時間枠：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)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Insulin resistance status (HOMA-IR)
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Chi Khanh Hoang, Specialist physician level 1、University of Medicine and Pharmacy of Ho Chi Minh City
- スタディディレクター：Nam Quang Tran, Associate professor - Doctorat、University of Medicine and Pharmacy of Ho Chi Minh City
- スタディディレクター：Tran Viet Thang, Doctorate、University of Medicine and Pharmacy of Ho Chi Minh City
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年2月24日
一次修了 (推定)
2027年12月1日
研究の完了 (推定)
2028年2月1日
試験登録日
最初に提出
2026年5月1日
QC基準を満たした最初の提出物
2026年5月1日
最初の投稿 (実際)
2026年5月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月7日
QC基準を満たした最後の更新が送信されました
2026年5月1日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。