NCT07574138招募中不适用
Comparison of Beta Cell Functional Changes in Patients With Early-onset Type 2 Diabetes Mellitus and Those With Typical Onset
University Medical Center Ho Chi Minh City (UMC)1 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2025年2月24日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 296
- 试验地点
- 1
研究概览
简要总结
- 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.
详细描述
- 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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
研究点 (1)
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