Diabetes Mellitus, Type 2AD-HET-KZNCT07522502
Metabolic and Immunoinflammatory Profiles in Adults With Newly Diagnosed Diabetes
An observational study of Diabetes Mellitus, Type 2 and Autoimmune Diabetes, run by West Kazakhstan Marat Ospanov Medical University at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Autoimmune Diabetes
- How many people
- 240 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 May 2024to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
West Kazakhstan Marat Ospanov Medical University
Aktobe, 030019
About this study
Official title: Clinical, Metabolic, and Immunoinflammatory Characteristics of Adult-Onset Diabetes at Diagnosis: A Cross-Sectional Study in the Kazakh Population
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:
Read more
- 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Autoimmune Diabetes
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (13)
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.
Measured: Baseline
Serum IL-1β Level
Measurement of serum interleukin-1 beta (IL-1β) levels in adults with newly diagnosed diabetes according to islet autoantibody status.
Measured: Baseline
Basal C-Peptide Level
Assessment of basal C-peptide concentration as a marker of beta-cell function in adults with newly diagnosed diabetes.
Measured: 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.
Measured: Baseline
HOMA2-%B
Assessment of beta-cell function using the HOMA2-%B index in adults with newly diagnosed diabetes.
Measured: Baseline
HbA1c
Assessment of glycemic control using glycated hemoglobin levels in adults with newly diagnosed diabetes.
Measured: Baseline
Islet Autoantibody Status
Determination of islet autoantibody positivity based on GADA, IA-2A, ZnT8A, and ICA testing in adults with newly diagnosed diabetes.
Measured: Baseline
Fasting Plasma Glucose
Measurement of fasting plasma glucose levels in adults with newly diagnosed diabetes.
Measured: Baseline
Fasting Insulin Level
Measurement of fasting insulin levels as part of metabolic assessment in adults with newly diagnosed diabetes.
Measured: Baseline
Glutamic Acid Decarboxylase Antibody (GADA) Positivity
Determination of glutamic acid decarboxylase antibody (GADA) positivity in adults with newly diagnosed diabetes.
Measured: Baseline
Islet Antigen-2 Antibody (IA-2A) Positivity
Determination of islet antigen-2 antibody (IA-2A) positivity in adults with newly diagnosed diabetes.
Measured: Baseline
Zinc Transporter 8 Antibody (ZnT8A)
Determination of zinc transporter 8 antibody (ZnT8A) positivity in adults with newly diagnosed diabetes.
Measured: Baseline
Islet Cell Antibody (ICA)
Determination of islet cell antibody (ICA) positivity in adults with newly diagnosed diabetes.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 May 2024
- Primary completion1 Jan 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Kazakhstan Marat Ospanov Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu
- Responsible party
- Principal investigator, Bibigul Tleumagambetova, West Kazakhstan Marat Ospanov Medical University
- Investigators
- Khatimya Kudabayeva, Study director, West Kazakhstan Marat Ospanov State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522502
- Sponsor's protocol ID
- AD-HET-KZ-2024
- Other IDs
- 13/2-19-25/1с-РТН
- Acronym
- AD-HET-KZ
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
https://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2026.1824856/full
Tleumagambetova B, Kudabayeva K, Bazargaliyev Y, Vudu L. IL-1beta/IL-1Ra ratio dysregulation in islet autoantibody-positive adult-onset diabetes. Front Immunol. 2026 Apr 10;17:1784582. doi: 10.3389/fimmu.2026.1784582. eCollection 2026.
PubMed 42039164Kudabayeva K, Tleumagambetova B, Bazargaliyev Y, Vudu L. Frequency of islet autoantibody seropositivity among adults with newly diagnosed type 2 diabetes in the Kazakh population: A cross-sectional study. J Diabetes Investig. 2026 Jun;17(6):970-978. doi: 10.1111/jdi.70312. Epub 2026 Apr 21.
PubMed 42012986
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Metabolic, and Immunoinflammatory Characteristics of Adult-Onset Diabetes at Diagnosis: A Cross-Sectional Study in the Kazakh Population
- ClinicalTrials.gov ID
- NCT07522502
- Acronym / sponsor ID
- AD-HET-KZ / AD-HET-KZ-2024
- Conditions
- Diabetes Mellitus, Type 2, Autoimmune Diabetes
- Keywords
- adult-onset diabetes, newly diagnosed diabetes, insulin resistance, beta-cell dysfunction, GADA, IA-2A, ZnT8A, ICA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- West Kazakhstan Marat Ospanov Medical UniversityUniversity, hospital or other
- Collaborators
- Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IL-1β / IL-1Ra Ratio
Time frame: 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.
13 secondary outcomes
Serum IL-1Ra Level
Time frame: Baseline
Serum IL-1β Level
Time frame: Baseline
Basal C-Peptide Level
Time frame: Baseline
HOMA2-IR
Time frame: Baseline
HOMA2-%B
Time frame: Baseline
HbA1c
Time frame: Baseline
Islet Autoantibody Status
Time frame: Baseline
Fasting Plasma Glucose
Time frame: Baseline
Fasting Insulin Level
Time frame: Baseline
Glutamic Acid Decarboxylase Antibody (GADA) Positivity
Time frame: Baseline
Islet Antigen-2 Antibody (IA-2A) Positivity
Time frame: Baseline
Zinc Transporter 8 Antibody (ZnT8A)
Time frame: Baseline
Islet Cell Antibody (ICA)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Results publicationhttps://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2026.1824856/full
- Results publication: PubMed 42039164Tleumagambetova B, Kudabayeva K, Bazargaliyev Y, Vudu L. IL-1beta/IL-1Ra ratio dysregulation in islet autoantibody-positive adult-onset diabetes. Front Immunol. 2026 Apr 10;17:1784582. doi: 10.3389/fimmu.2026.1784582. eCollection 2026.
- Results publication: PubMed 42012986Kudabayeva K, Tleumagambetova B, Bazargaliyev Y, Vudu L. Frequency of islet autoantibody seropositivity among adults with newly diagnosed type 2 diabetes in the Kazakh population: A cross-sectional study. J Diabetes Investig. 2026 Jun;17(6):970-978. doi: 10.1111/jdi.70312. Epub 2026 Apr 21.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khatimya Kudabayeva study director
West Kazakhstan Marat Ospanov State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Autoimmune Diabetes, run by West Kazakhstan Marat Ospanov Medical University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-1β / IL-1Ra Ratio (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07522502, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.