Clinical, Metabolic, and Immunoinflammatory Characteristics of Adult-Onset Diabetes at Diagnosis: A Cross-Sectional Study in the Kazakh Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- IL-1β / IL-1Ra Ratio
研究概览
简要总结
The goal of this observational study is to better understand how diabetes develops in adults at the time of diagnosis. The study focuses on adults with newly diagnosed diabetes in the Kazakh population.
The main questions it aims to answer are:
- How do insulin resistance and beta-cell function differ between participants?
- How is the immune system involved at the early stage of diabetes?
- How are inflammation markers related to metabolic changes?
Participants undergo clinical and laboratory assessments at diagnosis. These include:
- Measurement of body mass index (BMI) and blood glucose control (HbA1c)
- Assessment of insulin resistance and beta-cell function using HOMA2 indices
- Measurement of C-peptide levels
- Testing for islet autoantibodies (GADA, IA-2A, ZnT8A, ICA)
- Measurement of inflammatory markers, including interleukin-1 beta (IL-1β) and interleukin-1 receptor antagonist (IL-1Ra) This study aims to improve understanding of different forms of adult-onset diabetes and support more personalized approaches to diagnosis and treatment.
详细描述
Adult-onset diabetes is increasingly recognized as a heterogeneous condition with diverse underlying pathophysiological mechanisms. At the time of diagnosis, individuals may present with varying degrees of insulin resistance, impaired beta-cell function, and immune activation. However, traditional classifications based mainly on glycemic parameters do not fully capture this complexity.
This study aims to provide an integrated assessment of metabolic and immunoinflammatory features in adults with newly diagnosed diabetes. Particular attention is given to the interplay between insulin resistance, beta-cell function, and immune-mediated processes, including islet autoimmunity and inflammatory signaling pathways.
The study focuses on key metabolic indicators such as body mass index, glycemic control, C-peptide levels, and indices derived from the HOMA2 model, as well as immunological markers including islet autoantibodies and cytokines involved in the interleukin-1 pathway. The balance between pro-inflammatory and anti-inflammatory activity is assessed through the IL-1β/IL-1Ra ratio.
By integrating metabolic and immunological data, this study seeks to better characterize early-stage heterogeneity of adult-onset diabetes and to contribute to improved phenotypic classification. A more comprehensive understanding of these mechanisms may support the development of more personalized approaches to diagnosis and disease management in diverse populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 25 years and older
- •Kazakh population with newly diagnosed diabetes mellitus
- •Diagnosis established in routine clinical practice
- •No prior insulin therapy at the time of enrollment
- •No prior use of glucose-lowering therapy beyond initial management
- •Ability and willingness to provide informed consent
排除标准
- •Clinical features suggestive of classical type 1 diabetes at presentation
- •History of long-term insulin therapy prior to enrollment
- •Severe acute illness or infection at the time of assessment
- •Pregnancy
- •Incomplete clinical or laboratory data
研究组 & 干预措施
Islet Autoantibody-Positive Adults With Newly Diagnosed Diabetes
Adults with newly diagnosed diabetes who tested positive for at least one islet autoantibody (GADA, IA-2A, ZnT8A, or ICA). Participants undergo clinical and laboratory assessment at diagnosis, including metabolic parameters (BMI, HbA1c, C-peptide, HOMA2 indices) and inflammatory markers (IL-1β and IL-1Ra).
Islet Autoantibody-Negative Adults With Newly Diagnosed Diabetes
Adults with newly diagnosed diabetes who tested negative for all measured islet autoantibodies (GADA, IA-2A, ZnT8A, and ICA). Participants undergo the same clinical and laboratory assessments as the autoantibody-positive group at diagnosis.
结局指标
主要结局
IL-1β / IL-1Ra Ratio
时间窗: Baseline
Assessment of the serum IL-1β/IL-1Ra ratio as a marker of immunoinflammatory balance in adults with newly diagnosed diabetes, with comparison according to islet autoantibody status.
次要结局
- Serum IL-1Ra Level(Baseline)
- Serum IL-1β Level(Baseline)
- Basal C-Peptide Level(Baseline)
- HOMA2-IR(Baseline)
- HOMA2-%B(Baseline)
- HbA1c(Baseline)
- Islet Autoantibody Status(Baseline)
- Fasting Plasma Glucose(Baseline)
- Fasting Insulin Level(Baseline)
- Glutamic Acid Decarboxylase Antibody (GADA) Positivity(Baseline)
- Islet Antigen-2 Antibody (IA-2A) Positivity(Baseline)
- Zinc Transporter 8 Antibody (ZnT8A)(Baseline)
- Islet Cell Antibody (ICA)(Baseline)
研究者
Bibigul Tleumagambetova
PhD Candidate
West Kazakhstan Marat Ospanov Medical University