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Metabolic and Immunoinflammatory Profiles in Adults With Newly Diagnosed Diabetes

Clinical, Metabolic, and Immunoinflammatory Characteristics of Adult-Onset Diabetes at Diagnosis: A Cross-Sectional Study in the Kazakh Population

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07522502
Acronym
AD-HET-KZ
Enrollment
240
Registered
2026-04-13
Start date
2024-05-01
Completion date
2025-09-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diabetes, Diabetes Mellitus, Type 2

Keywords

adult-onset diabetes, newly diagnosed diabetes, insulin resistance, beta-cell dysfunction, GADA, IA-2A, ZnT8A, ICA, IL-1 beta, IL-1Ra, inflammation, cytokines, HOMA2, C-peptide, Kazakhstan, autoantibody-positive, autoantibody-negative

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

West Kazakhstan Marat Ospanov Medical University
Lead SponsorOTHER
Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu
CollaboratorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
IL-1β / IL-1Ra RatioBaselineAssessment 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.

Secondary

MeasureTime frameDescription
Serum IL-1Ra LevelBaselineMeasurement of serum interleukin-1 receptor antagonist (IL-1Ra) levels in adults with newly diagnosed diabetes according to islet autoantibody status.
Serum IL-1β LevelBaselineMeasurement of serum interleukin-1 beta (IL-1β) levels in adults with newly diagnosed diabetes according to islet autoantibody status.
Basal C-Peptide LevelBaselineAssessment of basal C-peptide concentration as a marker of beta-cell function in adults with newly diagnosed diabetes.
HOMA2-IRBaselineAssessment 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.
HOMA2-%BBaselineAssessment of beta-cell function using the HOMA2-%B index in adults with newly diagnosed diabetes.
HbA1cBaselineAssessment of glycemic control using glycated hemoglobin levels in adults with newly diagnosed diabetes.
Islet Autoantibody StatusBaselineDetermination of islet autoantibody positivity based on GADA, IA-2A, ZnT8A, and ICA testing in adults with newly diagnosed diabetes.
Fasting Plasma GlucoseBaselineMeasurement of fasting plasma glucose levels in adults with newly diagnosed diabetes.
Fasting Insulin LevelBaselineMeasurement of fasting insulin levels as part of metabolic assessment in adults with newly diagnosed diabetes.
Glutamic Acid Decarboxylase Antibody (GADA) PositivityBaselineDetermination of glutamic acid decarboxylase antibody (GADA) positivity in adults with newly diagnosed diabetes.
Islet Antigen-2 Antibody (IA-2A) PositivityBaselineDetermination of islet antigen-2 antibody (IA-2A) positivity in adults with newly diagnosed diabetes.
Zinc Transporter 8 Antibody (ZnT8A)BaselineDetermination of zinc transporter 8 antibody (ZnT8A) positivity in adults with newly diagnosed diabetes.
Islet Cell Antibody (ICA)BaselineDetermination of islet cell antibody (ICA) positivity in adults with newly diagnosed diabetes.

Countries

Kazakhstan

Contacts

STUDY_DIRECTORKhatimya Kudabayeva

West Kazakhstan Marat Ospanov State Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026