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| ID | Type | Description | Link |
|---|---|---|---|
| 13/2-19-25/1с-РТН | Other Grant/Funding Number | West Kazakhstan Marat Ospanov Medical University, |
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| Name | Class |
|---|---|
| Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu | OTHER |
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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:
Participants undergo clinical and laboratory assessments at diagnosis. These include:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| IL-1β / IL-1Ra Ratio | 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Serum IL-1Ra Level | Measurement of serum interleukin-1 receptor antagonist (IL-1Ra) levels in adults with newly diagnosed diabetes according to islet autoantibody status. | Baseline |
| Serum IL-1β Level |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with newly diagnosed diabetes recruited from primary health care settings in the Kazakh population. Participants were assessed at the time of diagnosis using clinical, metabolic, and immunological parameters.
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| Name | Affiliation | Role |
|---|---|---|
| Khatimya Kudabayeva | West Kazakhstan Marat Ospanov State Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Kazakhstan Marat Ospanov Medical University | Aktobe | 030019 | Kazakhstan |
Individual participant data (IPD) are not currently planned to be shared due to ethical considerations and restrictions related to informed consent. Data may be made available upon reasonable request and subject to approval by the institutional ethics committee.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Measurement of serum interleukin-1 beta (IL-1β) levels in adults with newly diagnosed diabetes according to islet autoantibody status.
| Baseline |
| Basal C-Peptide Level | Assessment of basal C-peptide concentration as a marker of beta-cell function in adults with newly diagnosed diabetes. | Baseline |
| HOMA2-IR | Assessment of insulin resistance using the HOMA2-IR index in adults with newly diagnosed diabetes. HOMA2-IR calculated from fasting glucose and fasting insulin at diagnosis. No fixed minimum or maximum score; higher scores indicate worse insulin resistance. In published population-based studies of adults, thresholds for insulin resistance typically range from approximately 1.8 to 2.0. | Baseline |
| HOMA2-%B | Assessment of beta-cell function using the HOMA2-%B index in adults with newly diagnosed diabetes. | Baseline |
| HbA1c | Assessment of glycemic control using glycated hemoglobin levels in adults with newly diagnosed diabetes. | Baseline |
| Islet Autoantibody Status | Determination of islet autoantibody positivity based on GADA, IA-2A, ZnT8A, and ICA testing in adults with newly diagnosed diabetes. | Baseline |
| Fasting Plasma Glucose | Measurement of fasting plasma glucose levels in adults with newly diagnosed diabetes. | Baseline |
| Fasting Insulin Level | Measurement of fasting insulin levels as part of metabolic assessment in adults with newly diagnosed diabetes. | Baseline |
| Glutamic Acid Decarboxylase Antibody (GADA) Positivity | Determination of glutamic acid decarboxylase antibody (GADA) positivity in adults with newly diagnosed diabetes. | Baseline |
| Islet Antigen-2 Antibody (IA-2A) Positivity | Determination of islet antigen-2 antibody (IA-2A) positivity in adults with newly diagnosed diabetes. | Baseline |
| Zinc Transporter 8 Antibody (ZnT8A) | Determination of zinc transporter 8 antibody (ZnT8A) positivity in adults with newly diagnosed diabetes. | Baseline |
| Islet Cell Antibody (ICA) | Determination of islet cell antibody (ICA) positivity in adults with newly diagnosed diabetes. | Baseline |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |